Buy me a coffee
Home › FDA recalls › Oxycodone and Acetaminophen CII Tablets USP
CLASS II · ModerateFDA

SpecGx, LLC recalls Oxycodone and Acetaminophen CII Tablets USP

📅 Dec 16, 2025 · 📍 Nationwide
Recalling company
SpecGx, LLC
Product
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493
Reason
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Dec 16, 2025
Reported
Jan 14, 2026
Distribution
Nationwide
Status
Ongoing
Quantity
74,544 bottles
Lot / codes
Lot: 0522J23493, expires: 03/2027.
Company location
Webster Groves, MO
Recall type
Voluntary: Firm initiated
Recall number
D-0255-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0255-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.