FDAHealthMarch 19, 2026

Amneal Pharmaceuticals, LLC — traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amnea

⚠️ 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).

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: March 19, 2026

Nationwide within the USA

What's affected?

Product: 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.
Brand: TRAMADOL HYDROCHLORIDE
Lot code: AM230987

Additional details

Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 29,542 bottles.

View original FDA notice →

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