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Home › FDA recalls › Morphine Sulfate Oral Solution 100 mg / 5 mL
CLASS III · LowFDA

Winder Laboratories, LLC recalls Morphine Sulfate Oral Solution 100 mg / 5 mL

📅 Nov 26, 2025 · 📍 Nationwide
Recalling company
Winder Laboratories, LLC
Product
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01
Reason
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Classification
Class III – not likely to cause adverse health consequences
Recall date
Nov 26, 2025
Reported
Dec 17, 2025
Distribution
U.S. Nationwide
Status
Ongoing
Quantity
3,528 30 mL Bottles
Lot / codes
Lot 1312405; Exp 09/28/2027
Company location
Winder, GA
Recall type
Voluntary: Firm initiated
Recall number
D-0223-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0223-2026 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.