Why it was recalled
Failed Impurities/Degradation Specification
Product description
Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.
Lot numbers, UPCs & expiration codes
Lot# FG13996, Exp 09/30/2025
Where it was sold
Nationwide 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-0037-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 22, 2024
- FDA report date
- Nov 13, 2024
- Quantity
- 532 100-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0037-2025, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95588
- Address
- 107 College Rd E
- Code information
- Lot# FG13996, Exp 09/30/2025
- Postal code
- 08540-6623
- Report date
- Nov 13, 2024
- Product type
- Drugs
- Recall number
- D-0037-2025
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 532 100-count bottles
- Reason for recall
- Failed Impurities/Degradation Specification
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 22, 2024
- Center classification date
- Nov 4, 2024