Recalls / Class III
Class IIID-0223-2026
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
- Brand name
- Morphine Sulfate
- Generic name
- Morphine Sulfate
- Active ingredient
- Morphine Sulfate
- Route
- Oral
- NDCs
- 75826-129, 75826-130, 75826-131
- FDA application
- ANDA211454
- Affected lot / code info
- Lot 1312405; Exp 09/28/2027
Why it was recalled
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Recalling firm
- Firm
- Winder Laboratories, LLC
- Manufacturer
- Winder Laboratories LLC
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 716 Patrick Industrial Ln, N/A, Winder, Georgia 30680-8333
Distribution
- Quantity
- 3,528 30 mL Bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-11-26
- FDA classified
- 2025-12-09
- Posted by FDA
- 2025-12-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0223-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.