Amneal Pharmaceuticals recalls 50mg traMADol hydrochloride tablets with NDSRI impurity exceeding stability limits. This may pose health risks if used beyond expiration.
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).
Amneal Pharmaceuticals is recalling 50mg traMADol hydrochloride tablets that contain an impurity (NDSRI) exceeding safety limits. This could pose health risks if the tablets are used after the expiration date.
The tablets contain an impurity (NDSRI) that exceeds the safety limits set for stability testing at 24 months. This impurity could potentially cause health issues if the tablets are used beyond their expiration date.
Prescription patients who have received the recalled 500-count bottles of 50mg traMADol hydrochloride tablets from Amneal Pharmaceuticals. Those with specific medical conditions requiring this medication are most at risk.
Check for the 500-count bottles labeled 'traMADol Hydrochloride Tablets, USP, 50 mg' with NDC 60219-2348-5. The lot numbers AM230987 (expiring 05/2026) and AR232387 (expiring 12/2026) are associated with this recall.
Verify the expiration date on the bottle; the recalled items expire by May 2026 or December 2026.
The recall indicates the product may have an impurity exceeding safety limits, so it is not recommended for use beyond the expiration date.
The recall does not specify a remedy, so contact your healthcare provider for advice on safe disposal or alternatives.
Look for the 500-count bottles with NDC 60219-2348-5 and lot numbers AM230987 (expiring 05/2026) or AR232387 (expiring 12/2026).
We’ve drafted a message you can send Amneal Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0408-2026 — Amneal Pharmaceuticals Amneal Pharmaceuticals Hello, I own a Amneal Pharmaceuticals that is covered by recall D-0408-2026 from Amneal Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
