Why it was recalled
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
Product description
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5.
Lot numbers, UPCs & expiration codes
Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.
Where it was sold
Nationwide within 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-0408-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 19, 2026
- FDA report date
- Apr 8, 2026
- Quantity
- 29,542 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0408-2026, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98623
- Address
- 400 Crossing Blvd Fl 3
- Code information
- Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.
- Postal code
- 08807-2863
- Report date
- Apr 8, 2026
- Product type
- Drugs
- Recall number
- D-0408-2026
- Classification
- Class II
- Recalling firm
- Amneal Pharmaceuticals, LLC
- Product quantity
- 29,542 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5.
- Distribution pattern
- Nationwide within the USA
- Recall initiation date
- Mar 19, 2026
- Center classification date
- Mar 30, 2026