Class IIIOngoing

Primidone Tablets recall

FDA recall D-0585-2026 · initiated Jun 3, 2026

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

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.

Details

Product: 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
Recalling company: Amneal
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide within the USA.
Initiated: Jun 3, 2026
FDA report date: Jun 17, 2026

This recall is linked to a product we cover: Primidone →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0585-2026 ↗

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