Morphine Sulfate Extended-Release Tablets — Class II drug recall D-0249-2025
Ongoing recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2025-03-12, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0249-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2025-02-06 |
| Classified | 2025-03-03 |
| Reported by FDA | 2025-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 9,840 bottles |
| Reason classes | specification failure |
| NDC | 63304-0450, 63304-0450-01, 63304-0450-03, 63304-0450-05, 63304-0451, 63304-0451-01, 63304-0451-03, 63304-0451-05, 63304-0452, 63304-0452-01, 63304-0452-03, 63304-0452-05, 63304-0453, 63304-0453-01, 63304-0453-03, 63304-0453-05, 63304-0758, 63304-0758-01, 63304-0758-03, 63304-0758-05, 63304-0758-50 |
| Lot numbers | AD16615 |
| Expiration dates | 2025-07 |
Product
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01
Reason for recall
Failed Dissolution Specifications
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-0249-2025. 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.