FDA Recall D-0223-2026
Winder Laboratories, LLC · Winder, GA
Class III Ongoing 169 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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 for recall
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Recall record
- Recall number
D-0223-2026- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- N/A
- Distribution
- U.S. Nationwide
- Recall initiated
- 2025-11-26
- Classified by FDA Center
- 2025-12-09
- FDA published
- 2025-12-17
- Recalling firm
- Winder Laboratories, LLC
- Firm location
- Winder, GA
Drug identification
- Brand name(s)
- MORPHINE SULFATE
- Generic name(s)
- MORPHINE SULFATE
- Manufacturer(s)
- Winder Laboratories LLC
- NDC(s)
75826-129, 75826-130, 75826-131- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.