FDA Recall D-0036-2025
Dr. Reddy's Laboratories, Inc. · Princeton, NJ
Class II Ongoing 569 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 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.
Reason for recall
Failed Impurities/Degradation Specification
Recall record
- Recall number
D-0036-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- N/A
- Distribution
- Nationwide in the USA
- Recall initiated
- 2024-10-22
- Classified by FDA Center
- 2024-11-04
- FDA published
- 2024-11-13
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Firm location
- Princeton, NJ
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.