FDA Recall D-0249-2025
SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ
Class II Ongoing 462 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0249-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within in the USA.
- Recall initiated
- 2025-02-06
- Classified by FDA Center
- 2025-03-03
- FDA published
- 2025-03-12
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Firm location
- Princeton, NJ
Drug identification
- Brand name(s)
- MORPHINE SULFATE
- Generic name(s)
- MORPHINE SULFATE
- Manufacturer(s)
- Sun Pharmaceutical Industries, Inc.
- NDC(s)
63304-450, 63304-451, 63304-758, 63304-452, 63304-453- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.