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Amneal Tramadol Hydrochloride 50mg Recall

TraMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220

Updated March 19, 2026

Amneal Pharmaceuticals is recalling Tramadol Hydrochloride 50 mg tablets (500-count bottles) because tests found an impurity called N-nitroso-desmethyl-tramadol that exceeded safe levels. This impurity can develop over time in stored medication and poses a potential health risk.

Is the Amneal Pharmaceuticals, LLC recalled? Yes. This product was recalled by FDA on March 19, 2026. Details below.

What is recalled

Tramadol Hydrochloride Tablets, USP, 50 mg, 500-count bottles. NDC number: 60219-2348-5. Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, India. Distributed by Amneal Pharmaceuticals LLC, Glasgow, KY 42141.

Am I affected

You're affected if you have a 500-count bottle of Tramadol Hydrochloride 50 mg tablets with NDC 60219-2348-5. Check the label on your bottle for this NDC number.

What to do right now

Stop taking this medication and contact your doctor or pharmacy right away. Do not return the medicine to a pharmacy on your own, your pharmacist or doctor will advise you on safe disposal and may provide a replacement.

The hazard

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).

Brands affected

Amneal Pharmaceuticals, LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0408-2026
Classification
Class II
Recalled
March 19, 2026
Read the official notice

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