Morphine Sulfate Oral Solution 100 mg / 5 mL — Class III drug recall D-0223-2026
Ongoing recall by Winder Laboratories, LLC, reported 2025-12-17, distributed nationwide. Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton
| Recall number | D-0223-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Winder Laboratories, LLC, Winder, GA, United States |
| Recall initiated | 2025-11-26 |
| Classified | 2025-12-09 |
| Reported by FDA | 2025-12-17 |
| Distributed | Nationwide (US) |
| Quantity | 3,528 |
| Reason classes | labeling |
| NDC | 75826-0129, 75826-0129-05, 75826-0129-17, 75826-0130, 75826-0130-05, 75826-0130-17, 75826-0131, 75826-0131-01, 75826-0131-04, 75826-0131-15 |
| Lot numbers | 1312405 |
| Expiration dates | 2027-09-28 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0223-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.