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Drug recalls (FDA)

Prescription and over-the-counter drug recalls from the FDA Enforcement Report and FDA announcements, newest first. Updated automatically every 30 minutes.

822recalls in the last 12 months
38Class I (most serious)
Oct 24, 2026most recent
CLASS I may cause serious illness or deathCLASS II temporary/reversible harmCLASS III unlikely to cause harm
FDA announcementFDA · Drug

Tonight We Ride, LLC Issues Voluntary Recall of Ultimate Forza Male Supplement Due to Presence of Undeclared Sildenafil, Tadalafil, and Dapo

Tonight We Ride, LLC
October 24, 2026, Tonight We Ride, LLC of Lakeville, Minnesota is voluntarily recalling all lots of Ultimate Forza Male Supplement capsules to the consumer level because it has beeโ€ฆ
๐Ÿ“… Oct 24, 2026 ยท ๐Ÿ“ MN
FDA announcementFDA · Drug

Wedgewood Pharmacy Issues Recall of Certain Compounded Veterinary Medications Within Expiry Due to Potential Potency Issues

Wedgewood Pharmacy
SWEDESBORO, N.J., (October 21, 2026) - Wedgewood Pharmacy LLC ("Wedgewood") is recalling certain compounded veterinary medications within expiry at the provider/customer level due โ€ฆ
๐Ÿ“… Oct 21, 2026 ยท ๐Ÿ“ See notice
CLASS II ยท ModerateFDA · Drug

Metoclopramide Tablets

American Health Packaging
Presence of Foreign Tablets/Capsules
๐Ÿ“… Oct 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Hydrocortisone Sodium Succinate for Injection

Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications.
๐Ÿ“… Oct 1, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Metoclopramide Tablets

Teva Pharmaceuticals USA, Inc
Presence of Foreign Tablets/Capsules
๐Ÿ“… Sep 29, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Lidocaine Ointment USP

Preferred Pharmaceuticals, Inc.
Failed Content Uniformity Specifications
๐Ÿ“… Sep 28, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Sermorelin

Houston Rx LLC
Lack of process control
๐Ÿ“… Sep 25, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Tirzepatide/Niacinamide 2mL vial

Houston Rx LLC
Lack of assurance of sterility.
๐Ÿ“… Sep 25, 2026 ยท ๐Ÿ“ Nationwide
CLASS III ยท LowFDA · Drug

Tretinoin Cream UPS

SUN PHARMACEUTICAL INDUSTRIES INC
Failed Impurities/Degradation Specifications
๐Ÿ“… Sep 25, 2026 ยท ๐Ÿ“ Nationwide
CLASS III ยท LowFDA · Drug

Tretinoin Cream USP

SUN PHARMACEUTICAL INDUSTRIES INC
Failed Impurities/Degradation Specifications
๐Ÿ“… Sep 25, 2026 ยท ๐Ÿ“ Nationwide
CLASS III ยท LowFDA · Drug

Tretinoin Cream USP

SUN PHARMACEUTICAL INDUSTRIES INC
Failed Impurities/Degradation Specifications
๐Ÿ“… Sep 25, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Apothecary NAD+ Injection 200 mg/mL

Apothecary Pharma LLC
Lack of Assurance of Sterility
๐Ÿ“… Sep 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Tirzepatide Injection

Apothecary Pharma LLC
Lack of Assurance of Sterility
๐Ÿ“… Sep 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Paroxetine Extended-Release Tablets

Apotex Corp.
Failed dissolution specifications.
๐Ÿ“… Sep 23, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

IMAAVY

J&J INNOVATIVE MEDICINE
Presence of particulate matter.
๐Ÿ“… Sep 23, 2026 ยท ๐Ÿ“ OH
CLASS II ยท ModerateFDA · Drug

Fosfomycin Tromethamine Granules for Oral Solution

Cipla USA, Inc.
Failed Impurities/Degradation Specifications
๐Ÿ“… Sep 18, 2026 ยท ๐Ÿ“ Nationwide
UnclassifiedFDA · Drug

amazon

Aurobindo Pharma USA Inc
Discoloration: consumer complaints received for discolored tablets
๐Ÿ“… Sep 18, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

FOCUS PI Hypromellose 0.7% Formula

Aurolab Trust
Lack of Assurance of Sterility
๐Ÿ“… Sep 17, 2026 ยท ๐Ÿ“ VA
CLASS II ยท ModerateFDA · Drug

Ranolazine Extended-Release Tablets

Ajanta Pharma USA Inc
Failed Dissolution Specifications: below specification
๐Ÿ“… Sep 17, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Clear Eyes Redness Relief

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Lack of Assurance of Sterility
๐Ÿ“… Sep 15, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Clear Eyes Redness Relief

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Lack of Assurance of Sterility
๐Ÿ“… Sep 15, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Sterile High Performance Ultra Lubricating Eye Drops

K.C. Pharmaceuticals, Inc.
Lack of Assurance of Sterility
๐Ÿ“… Sep 11, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Sterile Eye Drops Redness Relief

K.C. Pharmaceuticals, Inc.
Lack of Assurance of Sterility
๐Ÿ“… Sep 11, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Sterile Eye Drops

K.C. Pharmaceuticals, Inc.
Lack of Assurance of Sterility
๐Ÿ“… Sep 11, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Sterile Lubricant Dry Eye Relief Eye Drops

K.C. Pharmaceuticals, Inc.
Lack of Assurance of Sterility
๐Ÿ“… Sep 11, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Eye Drops MAXIMUM

K.C. Pharmaceuticals, Inc.
Lack of Assurance of Sterility
๐Ÿ“… Sep 11, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Sterile EYE DROPS Advanced Relief

K.C. Pharmaceuticals, Inc.
Lack of Assurance of Sterility
๐Ÿ“… Sep 11, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Sterile EYE DROPS AC

K.C. Pharmaceuticals, Inc.
Lack of Assurance of Sterility
๐Ÿ“… Sep 11, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Artificial Tears Sterile Lubricant Eye Drops

K.C. Pharmaceuticals, Inc.
Lack of Assurance of Sterility
๐Ÿ“… Sep 11, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Tri-MIX

Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
๐Ÿ“… Sep 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Tri-MIX

Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
๐Ÿ“… Sep 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE

Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
๐Ÿ“… Sep 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE

Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
๐Ÿ“… Sep 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE

Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
๐Ÿ“… Sep 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE

Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
๐Ÿ“… Sep 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE

Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
๐Ÿ“… Sep 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Tri-MIX

Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
๐Ÿ“… Sep 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Tri-MIX

Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
๐Ÿ“… Sep 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Tri-MIX

Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
๐Ÿ“… Sep 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Tri-MIX

Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
๐Ÿ“… Sep 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

QUAD-MIX

Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
๐Ÿ“… Sep 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

SERMORELIN ACETATE 1 MG/ML INJECTABLE

Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
๐Ÿ“… Sep 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE

Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
๐Ÿ“… Sep 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

SEMAGLUTIDE 3 MG/ML INJECTABLE

Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
๐Ÿ“… Sep 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

TIRZEPATIDE 26 MG/ML INJECTABLE

Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
๐Ÿ“… Sep 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Buprenorphine Hydrochloride

Par Health USA, LLC
Crystallization
๐Ÿ“… Sep 8, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Estradiol Gel

Amneal Pharmaceuticals, LLC
Defective Container; packets were found to be either empty or partially full.
๐Ÿ“… Sep 8, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Dopamine HCl Inj.

Pfizer
Lack of Assurance of Sterility
๐Ÿ“… Sep 4, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

fentaNYL Citrate

OurPharma LLC
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
๐Ÿ“… Sep 3, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Chlorthalidone Tablets

Inventia Healthcare Limited
Failed Dissolution Specifications
๐Ÿ“… Sep 3, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Benzoyl Peroxide Wash

SV Labs Toronto Corporation
Microbial contamination of topical product.
๐Ÿ“… Sep 1, 2026 ยท ๐Ÿ“ IL
CLASS II ยท ModerateFDA · Drug

Benzoyl Peroxide Wash

SV Labs Toronto Corporation
Microbial contamination of topical product.
๐Ÿ“… Sep 1, 2026 ยท ๐Ÿ“ IL
CLASS II ยท ModerateFDA · Drug

Zoladex

TerSera Therapeutics LLC
Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
๐Ÿ“… Aug 31, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Lidocaine Ointment USP

SUN PHARMA /TARO
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25ยฟC,60%RH).
๐Ÿ“… Aug 31, 2026 ยท ๐Ÿ“ Nationwide
CLASS III ยท LowFDA · Drug

Trokendi XR

Supernus Pharmaceuticals, Inc.
Failed dissolution specifications.
๐Ÿ“… Aug 31, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Exenatide Injection

Amneal Pharmaceuticals of New York, LLC
Defective Delivery System: Possibility of no medication in the prefilled pen.
๐Ÿ“… Aug 28, 2026 ยท ๐Ÿ“ Nationwide
CLASS III ยท LowFDA · Drug

Olanzapine Tablets

Macleods Pharmaceuticals Limited
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
๐Ÿ“… Aug 27, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Carton label: Mycophenolate Mofetil for injection

Mylan Pharmaceuticals Inc
Failed Dissolution Specifications
๐Ÿ“… Aug 26, 2026 ยท ๐Ÿ“ Nationwide
CLASS III ยท LowFDA · Drug

Fluphenazine Hydrochloride Tablets

Ajanta Pharma USA Inc
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 โ€ฆ
๐Ÿ“… Aug 25, 2026 ยท ๐Ÿ“ Nationwide
CLASS III ยท LowFDA · Drug

Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution

ImprimisRx NJ LLC
Subpotent Drug
๐Ÿ“… Aug 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

traZODone Hydrochloride Tablets

Teva Pharmaceuticals USA, Inc
Presence of Foreign Tablets/Capsules
๐Ÿ“… Aug 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Ramipril Capsules USP

Hikma Pharmaceuticals USA INC.
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
๐Ÿ“… Aug 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS I ยท SeriousFDA · Drug

Thyroid Tablets

VITRUVIAS THERAPEUTICS INC
Superpotent Drug
๐Ÿ“… Aug 21, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Prasugrel HCI

Golden State Medical Supply Inc.
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
๐Ÿ“… Aug 21, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Broadway Joe's Pain Cream

Lexia LLC
CGMP Deviations: Potential contamination of raw material
๐Ÿ“… Aug 21, 2026 ยท ๐Ÿ“ CO
CLASS II ยท ModerateFDA · Drug

Broadway Joe's Pain Cream

Lexia LLC
CGMP Deviations: Potential contamination of raw material
๐Ÿ“… Aug 21, 2026 ยท ๐Ÿ“ CO
CLASS II ยท ModerateFDA · Drug

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%

Sterling Pharmaceutical Services LLC
Lack of Assurance of Sterility
๐Ÿ“… Aug 20, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Lubricant Eye Drops-Cameron Pharmaceuticals

Sterling Pharmaceutical Services LLC
Lack of Assurance of Sterility
๐Ÿ“… Aug 20, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Major LubriFresh P.M. Nighttime Ointment

Sterling Pharmaceutical Services LLC
Lack of Assurance of Sterility
๐Ÿ“… Aug 20, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

TRP The Relief Products* Gentle Eyes Lubricant Eye Drops

Sterling Pharmaceutical Services LLC
Lack of Assurance of Sterility
๐Ÿ“… Aug 20, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Reliable-1 Laboratories Lubricating Tears

Sterling Pharmaceutical Services LLC
Lack of Assurance of Sterility
๐Ÿ“… Aug 20, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Walgreens Lubricant Eye Drops

Sterling Pharmaceutical Services LLC
Lack of Assurance of Sterility
๐Ÿ“… Aug 20, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Walgreens Lubricant Eye Drops

Sterling Pharmaceutical Services LLC
Lack of Assurance of Sterility
๐Ÿ“… Aug 20, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Reliable -1 Laboratories

Sterling Pharmaceutical Services LLC
Lack of Assurance of Sterility
๐Ÿ“… Aug 20, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%

Sterling Pharmaceutical Services LLC
Lack of Assurance of Sterility
๐Ÿ“… Aug 20, 2026 ยท ๐Ÿ“ Nationwide
CLASS I ยท SeriousFDA · Drug

0.9% Sodium Chloride Injection

B BRAUN MEDICAL INC
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
๐Ÿ“… Aug 19, 2026 ยท ๐Ÿ“ Nationwide
CLASS III ยท LowFDA · Drug

Buprenorphine Sublingual Tablets

American Health Packaging
Labeling: Label Mix-up
๐Ÿ“… Aug 19, 2026 ยท ๐Ÿ“ Nationwide
CLASS III ยท LowFDA · Drug

Revcovi

Chiesi USA, Inc.
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
๐Ÿ“… Aug 19, 2026 ยท ๐Ÿ“ MO, TN
CLASS II ยท ModerateFDA · Drug

2% Chlorhexidine Gluconate* Cloth

Sage Products, LLC
Cross Contamination with Other Products
๐Ÿ“… Aug 18, 2026 ยท ๐Ÿ“ Nationwide
CLASS I ยท SeriousFDA · Drug

Dextrose Injection

Baxter Healthcare Corporation
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
๐Ÿ“… Aug 17, 2026 ยท ๐Ÿ“ Nationwide
CLASS I ยท SeriousFDA · Drug

0.9% Sodium Chloride Injection USP 500 mL

Baxter Healthcare Corporation
Presence of particulate matter: Particulates identified as fiberglass
๐Ÿ“… Aug 17, 2026 ยท ๐Ÿ“ See notice
CLASS II ยท ModerateFDA · Drug

Prasugrel Tablets

Mylan Pharmaceuticals Inc
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
๐Ÿ“… Aug 17, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL

Allies Group Inc.
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
๐Ÿ“… Aug 14, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL

Allies Group Inc.
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
๐Ÿ“… Aug 14, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL

Allies Group Inc.
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
๐Ÿ“… Aug 14, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL

Allies Group Inc.
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
๐Ÿ“… Aug 14, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Fluphenazine HCl Elixir

Safecor Health, LLC
Failed Stability Specifications
๐Ÿ“… Aug 13, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Fluphenazine HCl Elixir

Safecor Health, LLC
Failed Stability Specifications
๐Ÿ“… Aug 13, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Fluphenazine HCl Elixir

Safecor Health, LLC
Failed Stability Specifications
๐Ÿ“… Aug 13, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Fluphenazine HCl Elixir

Safecor Health, LLC
Failed Stability Specifications
๐Ÿ“… Aug 13, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Fluphenazine HCl Elixir

Safecor Health, LLC
Failed Stability Specifications
๐Ÿ“… Aug 13, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Fluphenazine HCl Elixir

Safecor Health, LLC
Failed Stability Specifications
๐Ÿ“… Aug 13, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Paxil CR

Apotex Corp.
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
๐Ÿ“… Aug 13, 2026 ยท ๐Ÿ“ Nationwide
CLASS I ยท SeriousFDA · Drug

Lactated Ringer's Injection USP

B BRAUN MEDICAL INC
Presence of Particulate matter.
๐Ÿ“… Aug 12, 2026 ยท ๐Ÿ“ Nationwide
CLASS I ยท SeriousFDA · Drug

Epinephrine Injection

American Regent, Inc.
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
๐Ÿ“… Aug 11, 2026 ยท ๐Ÿ“ Nationwide
CLASS I ยท SeriousFDA · Drug

Tyenne

Fresenius Kabi USA, LLC
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
๐Ÿ“… Aug 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Zicam

Church & Dwight Co., Inc.
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
๐Ÿ“… Aug 10, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++

SHANTOU Qiwei industrial Co., Ltd
cGMP Deviations
๐Ÿ“… Aug 8, 2026 ยท ๐Ÿ“ CA
CLASS III ยท LowFDA · Drug

Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg

Bionpharma Inc.
Presence of Foreign Tablets/Capsules
๐Ÿ“… Aug 7, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Carbamazepine Tablets

Golden State Medical Supply Inc.
CGMP deviations: tablets with black specks.
๐Ÿ“… Aug 7, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Daptomycin

Baxter Healthcare Corporation
CGMP Deviations
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Vancomycin Injection

Baxter Healthcare Corporation
CGMP Deviations
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Vasopressin

Baxter Healthcare Corporation
CGMP Deviations
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Clindamycin Injection USP in 5% Dextrose

Baxter Healthcare Corporation
CGMP Deviations
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Clindamycin Injection USP in 5% Dextrose

Baxter Healthcare Corporation
CGMP Deviations
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Clindamycin Phosphate in 0.9% Sodium Chloride Injection

Baxter Healthcare Corporation
CGMP Deviations
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Clindamycin Injection USP in 5% Dextrose

Baxter Healthcare Corporation
CGMP Deviations
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Nexterone

Baxter Healthcare Corporation
CGMP Deviations
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

CARDENE IV

Baxter Healthcare Corporation
CGMP Deviations
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Pantoprazole Sodium in 0.9% Sodium Chloride Injection

Baxter Healthcare Corporation
CGMP Deviations
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Vasopressin

Baxter Healthcare Corporation
CGMP Deviations
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection

Baxter Healthcare Corporation
CGMP Deviations
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Famotidine Injection in Sodium Chloride Injection

Baxter Healthcare Corporation
CGMP Deviations
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Clindamycin Injection USP in 5% Dextrose

Baxter Healthcare Corporation
CGMP Deviations
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Daptomycin

Baxter Healthcare Corporation
CGMP Deviations
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

MYXREDLIN

Baxter Healthcare Corporation
CGMP Deviations
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Vancomycin Injection

Baxter Healthcare Corporation
CGMP Deviations
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Acthar Gel

Mallinckrodt Hospital Products Inc.
Presence of particulate matter: glass and stopper piece
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC.
Subpotent Drug
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC.
Subpotent Drug
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC.
Subpotent Drug
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC.
Subpotent Drug
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC.
Subpotent Drug
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC.
Subpotent Drug
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC.
Subpotent Drug
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC.
Subpotent Drug
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC.
Subpotent Drug
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC.
Subpotent Drug
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC.
Subpotent Drug
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Levothyroxine Sodium Tablets

ACCORD HEALTHCARE, INC.
Subpotent Drug
๐Ÿ“… Aug 6, 2026 ยท ๐Ÿ“ Nationwide
CLASS I ยท SeriousFDA · Drug

Glutathione 200 mg/mL

OPTIMAL BALANCE PHARMACY
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
๐Ÿ“… Aug 5, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Mirabegron Extended-Release Tablets

Zydus Pharmaceuticals (USA) Inc
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
๐Ÿ“… Aug 5, 2026 ยท ๐Ÿ“ Nationwide
CLASS I ยท SeriousFDA · Drug

Morphine Sulfate Injection

Fresenius Kabi USA, LLC
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
๐Ÿ“… Aug 4, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Diovan

Novartis Pharmaceuticals Corporation
Failed Dissolution Specifications
๐Ÿ“… Aug 4, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Clobetasol Propionate Cream USP

Lupin Pharmaceuticals Inc.
Failed content uniformity specifications.
๐Ÿ“… Aug 3, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Carbamazepine Tablets

SUN PHARMACEUTICAL INDUSTRIES INC
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
๐Ÿ“… Aug 3, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

SILDENAFIL CITRATE USP

Shoolin Pharma Chem LLP
CGMP Deviations:Noted during FDA inspection
๐Ÿ“… Aug 3, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

TADALAFIL USP

Shoolin Pharma Chem LLP
CGMP Deviations:Noted during FDA inspection
๐Ÿ“… Aug 3, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

TADALAFIL USP

Shoolin Pharma Chem LLP
CGMP Deviations:Noted during FDA inspection
๐Ÿ“… Aug 3, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

TADALAFIL USP

Shoolin Pharma Chem LLP
CGMP Deviations:Noted during FDA inspection
๐Ÿ“… Aug 3, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

SILDENAFIL CITRATE USP

Shoolin Pharma Chem LLP
CGMP Deviations:Noted during FDA inspection
๐Ÿ“… Aug 3, 2026 ยท ๐Ÿ“ Nationwide
CLASS I ยท SeriousFDA · Drug

Optiray Imaging Bulk Package-350

Liebel-Flarsheim Company LLC
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
๐Ÿ“… Jul 31, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION

Heritage Pharmaceuticals Inc
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
๐Ÿ“… Jul 30, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

CLEAR EYES Maximum Itchy Eye Relief

Prestige Brands Holdings
Lack of assurance of sterility. The recall is due to potential contamination
๐Ÿ“… Jul 29, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

PEMRYDI RTU

Shilpa Medicare Limited
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
๐Ÿ“… Jul 29, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

PEMRYDI RTU

Shilpa Medicare Limited
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
๐Ÿ“… Jul 29, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

SEMAGLUTIDE 20mg

Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
๐Ÿ“… Jul 29, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

SEMAGLUTIDE 10mg

Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
๐Ÿ“… Jul 29, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

SEMAGLUTIDE 7.5mg

Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
๐Ÿ“… Jul 29, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

SEMAGLUTIDE 5mg

Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
๐Ÿ“… Jul 29, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

SEMAGLUTIDE 2.5mg

Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
๐Ÿ“… Jul 29, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

SEMAGLUTIDE 0.9mg

Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
๐Ÿ“… Jul 29, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

SEMAGLUTIDE 9mg

Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
๐Ÿ“… Jul 29, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

SEMAGLUTIDE 4.5mg

Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
๐Ÿ“… Jul 29, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

SEMAGLUTIDE 6.75mg

Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
๐Ÿ“… Jul 29, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

SEMAGLUTIDE 2.25MG

Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
๐Ÿ“… Jul 29, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

SEMAGLUTIDE 12.5MG

Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
๐Ÿ“… Jul 29, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Biospectra Tris/Tromethamine

BioSpectra, Inc.
Failed stability specifications
๐Ÿ“… Jul 29, 2026 ยท ๐Ÿ“ CA
CLASS II ยท ModerateFDA · Drug

Libtayo

Regeneron Pharmaceuticals Inc
Lack of Assurance of Sterility
๐Ÿ“… Jul 28, 2026 ยท ๐Ÿ“ Nationwide
UnclassifiedFDA · Drug

Tri-Immune Boost

Centric Compounding LLC
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
๐Ÿ“… Jul 27, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

niCARdipine Hydrochloride Injection

American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
๐Ÿ“… Jul 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Tralement

American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
๐Ÿ“… Jul 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS I ยท SeriousFDA · Drug

Papaverine HCl Injection

American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
๐Ÿ“… Jul 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Multrys

American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
๐Ÿ“… Jul 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Selenious Acid Injection

American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
๐Ÿ“… Jul 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

ACETYLCYSTEINE SOLUTION

American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
๐Ÿ“… Jul 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

ACETYLCYSTEINE SOLUTION

American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
๐Ÿ“… Jul 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Atropine Sulfate injection

American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
๐Ÿ“… Jul 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

AMINAOCAPROIC ACID INJECTION

American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
๐Ÿ“… Jul 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Cyanocobalamin injection USP

American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
๐Ÿ“… Jul 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Cyanocobalamin injection USP

American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
๐Ÿ“… Jul 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Nitroglycerin injection

American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
๐Ÿ“… Jul 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS I ยท SeriousFDA · Drug

Cefazolin in Dextrose

Baxter Healthcare Corporation
Presence of Particulate Matter
๐Ÿ“… Jul 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Acamprosate Calcium

Mylan Pharmaceuticals Inc
Failed Dissolution Specifications
๐Ÿ“… Jul 24, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Dicyclomine Hydrochloride Capsules

Aurobindo Pharma USA Inc
shortfill; reports of empty capsules.
๐Ÿ“… Jul 23, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Azelaic Acid Gel

Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
๐Ÿ“… Jul 23, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Dorzolamide HCl and Timolol Maleate Ophthalmic Solution

MICRO LABS USA INC
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
๐Ÿ“… Jul 22, 2026 ยท ๐Ÿ“ Nationwide
CLASS I ยท SeriousFDA · Drug

Cyclophosphamide for Injection

Sunny Pharmtech Inc.
Presence of Particulate Matter; identified as stainless steel
๐Ÿ“… Jul 17, 2026 ยท ๐Ÿ“ Nationwide
CLASS I ยท SeriousFDA · Drug

Cyclophosphamide for Injection

Sunny Pharmtech Inc.
Presence of Particulate Matter; identified as stainless steel
๐Ÿ“… Jul 17, 2026 ยท ๐Ÿ“ Nationwide
CLASS III ยท LowFDA · Drug

Total Parental Nutrition

Central Admixture Pharmacy Services Inc
Incorrect Product Formulation
๐Ÿ“… Jul 16, 2026 ยท ๐Ÿ“ GA
CLASS III ยท LowFDA · Drug

Dabigatran Etexilate Capsules

Ascend Laboratories, LLC
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
๐Ÿ“… Jul 16, 2026 ยท ๐Ÿ“ Nationwide
CLASS III ยท LowFDA · Drug

Dabigatran Etexilate Capsules

Ascend Laboratories, LLC
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
๐Ÿ“… Jul 16, 2026 ยท ๐Ÿ“ Nationwide
CLASS III ยท LowFDA · Drug

Dabigatran Etexilate Capsules

Ascend Laboratories, LLC
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
๐Ÿ“… Jul 16, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Xylocaine

Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in products
๐Ÿ“… Jul 16, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Xylocaine

Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in products
๐Ÿ“… Jul 16, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Naropin

Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in products
๐Ÿ“… Jul 16, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Lidocaine HCl Injection

Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in products
๐Ÿ“… Jul 16, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Glycopyrrolate Injection

Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in product
๐Ÿ“… Jul 16, 2026 ยท ๐Ÿ“ Nationwide
CLASS III ยท LowFDA · Drug

Lidolog Kit

Asclemed USA Inc.
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
๐Ÿ“… Jul 15, 2026 ยท ๐Ÿ“ TN
CLASS II ยท ModerateFDA · Drug

Glycopyrrolate Oral Solution

Precision Dose Inc.
Failed Impurities/Degradation Specifications
๐Ÿ“… Jul 14, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Rohto Cooling Eye Drops Cool Relief

Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
๐Ÿ“… Jul 14, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Rohto Cooling Eye Drops Dry Aid

Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
๐Ÿ“… Jul 14, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Rohto Cooling Eye Drops Dry Aid

Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
๐Ÿ“… Jul 14, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Rohto Cooling Eye Drops Digi Eye

Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
๐Ÿ“… Jul 14, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Rohto Cooling Eye Drops Optic Glow

Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
๐Ÿ“… Jul 14, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Rohto Cooling Eye Drops Max Strength

Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
๐Ÿ“… Jul 14, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Rohto Cooling Eye Drops Max Strength

Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
๐Ÿ“… Jul 14, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Rohto Cooling Eye Drops ALL-IN-ONE

Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
๐Ÿ“… Jul 14, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Rising

Rising Pharma Holding, Inc.
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
๐Ÿ“… Jul 13, 2026 ยท ๐Ÿ“ Nationwide
CLASS II ยท ModerateFDA · Drug

Levothyroxine Sodium Tablets

Major Pharmaceuticals
Subpotent Drug
๐Ÿ“… Jul 13, 2026 ยท ๐Ÿ“ Nationwide

Search all 822 โ†’

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Frequently asked questions

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Check the NDC and lot number on your package against the notice. Do not stop a prescribed medicine without talking to your doctor or pharmacist; they can arrange a replacement.

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Directly from official U.S. government data: the FDA Enforcement Report (openFDA), USDA FSIS recalls and public health alerts, and the CPSC recalls database. Always check the official notice linked on each recall.