FDA Drugs recall ·
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles… recall
- Recall number
- D-0249-2025
- Date
- (initiated February 6, 2025)
- Company / brand
- Sun Pharmaceutical Industries Inc
2 Independence Way, Princeton, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 9840 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Dissolution Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: AD16615, Exp. Date 07/2025
Distribution
Nationwide within in the USA.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0249-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.