Recalls / Class II
Class IID-0249-2025
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
- Brand name
- Morphine Sulfate
- Generic name
- Morphine Sulfate
- Active ingredient
- Morphine Sulfate
- Route
- Oral
- NDCs
- 63304-450, 63304-451, 63304-758, 63304-452, 63304-453
- FDA application
- ANDA078761
- Affected lot / code info
- Lot #: AD16615, Exp. Date 07/2025
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 9840 bottles
- Distribution pattern
- Nationwide within in the USA.
Timeline
- Recall initiated
- 2025-02-06
- FDA classified
- 2025-03-03
- Posted by FDA
- 2025-03-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0249-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.