Which brands are affected?

The following brands are affected: TRAMADOL HYDROCHLORIDE, Amneal Pharmaceuticals NY LLC.

Which model numbers are affected?

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

HIGHMarch 19, 2026

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,...

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).

Quick Facts at a Glance

Recall Date: March 19, 2026
Hazard Level: HIGH
Brands: TRAMADOL HYDROCHLORIDE, Amneal Pharmaceuticals NY LLC
Geographic Scope: 1 states

Hazard Information

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).

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Amneal Pharmaceuticals, LLC or your healthcare provider for guidance

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Full 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.. Generic: TRAMADOL HYDROCHLORIDE; Brand: TRAMADOL HYDROCHLORIDE. Reason: 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).. Classification: Class II. Quantity: 29,542 bottles. Distribution: Nationwide within the USA

View Original Recall on FDA - Drug Safety

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Product Classification

Product Details

Brands

TRAMADOL HYDROCHLORIDE Amneal Pharmaceuticals NY LLC

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