FDA Drug recall D-0249-2025
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08…
- FDA Drug
- Class II
- ongoing
- Published 2025-03-12
On 2025-03-12 the FDA classified a Class II recall of Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08… by Sun Pharmaceutical Industries, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0249-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-06 |
| Published | 2025-03-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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
Failed Dissolution Specifications
Identifiers
| ndc | 63304-450-03 |
|---|---|
| ndc | 63304-450-01 |
| ndc | 63304-450-05 |
| ndc | 63304-451-03 |
| ndc | 63304-451-01 |
| ndc | 63304-451-05 |
| ndc | 63304-758-03 |
| ndc | 63304-758-01 |
| ndc | 63304-758-05 |
| ndc | 63304-758-50 |
| ndc | 63304-452-03 |
| ndc | 63304-452-01 |
| ndc | 63304-452-05 |
| ndc | 63304-453-03 |
| ndc | 63304-453-01 |
| ndc | 63304-453-05 |
| code_info | Lot #: AD16615, Exp. Date 07/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0249-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.