Recalls / Class II
Class IID-0037-2025
Product
Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.
- Affected lot / code info
- Lot# FG13996, Exp 09/30/2025
Why it was recalled
Failed Impurities/Degradation Specification
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 532 100-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-10-22
- FDA classified
- 2024-11-04
- Posted by FDA
- 2024-11-13
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0037-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.