Amneal Pharmaceuticals recalls Primidone 50mg tablets due to potential cross-contamination with Acemetacin API. Affected lots manufactured in India, expiring Nov 2028. No specific remedy stated in recall notice.
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Amneal Pharmaceuticals is recalling Primidone 50mg tablets that may have been contaminated with Acemetacin API during manufacturing. This cross-contamination could pose a health risk to patients taking these medications.
The tablets may have been contaminated with Acemetacin API during manufacturing in India. This cross-contamination could lead to unintended medication effects or health risks for patients taking the medication.
Patients prescribed Primidone tablets by a healthcare provider are affected. Those using the specific lot numbers mentioned in the recall are at most risk.
Check for the NDC code 53746-544-01 and lot number AM251676 on the bottle. The tablets were manufactured in Ahmedabad, India and expire November 30, 2028.
Look for the NDC code 53746-544-01 and lot number AM251676 on the bottle label.
The recall notice does not state any remedy or action steps for consumers.
The recall states there is a potential for cross-contamination with Acemetacin API, which could pose health risks to patients taking the medication.
Check for the NDC code 53746-544-01 and lot number AM251676 on the bottle label.
We’ve drafted a message you can send Amneal Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0585-2026 — Amneal Pharmaceuticals Amneal Pharmaceuticals Hello, I own a Amneal Pharmaceuticals that is covered by recall D-0585-2026 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.
