Primidone Tablets recall
Amneal Pharmaceuticals, LLC recalled Primidone Tablets on June 17, 2026 because of cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. It was sold nationwide.
Why it was recalled
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
What's recalled
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
Quantity: 27,936 100-count bottles
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Amneal Pharmaceuticals, LLC, Bridgewater, NJ
- Date
- Severity
- Class III
the product is unlikely to cause health problems but breaks a rule. - Where sold
- Nationwide
Nationwide within the USA. - Status
- Ongoing
- Recall number
- D-0585-2026
- Source
- U.S. Food and Drug Administration
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