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.
Other recalls by Sun Pharmaceutical Industries
- Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., B…
FDA Drug · Class III · 2026-10-14 · Sun Pharmaceutical Industries - Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuti…
FDA Drug · Class III · 2026-10-14 · Sun Pharmaceutical Industries - Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmac…
FDA Drug · Class III · 2026-10-14 · Sun Pharmaceutical Industries - Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 262…
FDA Drug · Class II · 2026-08-26 · Sun Pharmaceutical Industries - Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswic…
FDA Drug · Class III · 2026-07-08 · Sun Pharmaceutical Industries
All Sun Pharmaceutical Industries recalls
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.