Morphine Sulfate Extended-Release Tablets 15 mg — Class II drug recall D-0036-2025
Ongoing recall by Dr. Reddy's Laboratories, Inc., reported 2024-11-13, distributed nationwide. Failed Impurities/Degradation Specification
| Recall number | D-0036-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2024-10-22 |
| Classified | 2024-11-04 |
| Reported by FDA | 2024-11-13 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 51862-0185-01 |
| Lot numbers | FG14062 |
| Expiration dates | 2025-10-31 |
Product
Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.
Reason for recall
Failed Impurities/Degradation Specification
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-0036-2025. 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.