Why it was recalled
Failed Dissolution Specifications
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: AD16615, Exp. Date 07/2025
Where it was sold
Nationwide within in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0249-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 6, 2025
- FDA report date
- Mar 12, 2025
- Quantity
- 9840 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0249-2025, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96242
- Address
- 2 Independence Way
- Code information
- Lot #: AD16615, Exp. Date 07/2025
- Postal code
- 08540-6620
- Report date
- Mar 12, 2025
- Product type
- Drugs
- Recall number
- D-0249-2025
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 9840 bottles
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within in the USA.
- Recall initiation date
- Feb 6, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 3, 2025