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FDAClass III · Drug · Recalled June 17, 2026

Primidone Tablets recall — Amneal Pharmaceuticals, LLC

Hazard: Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

Class III: not likely to cause adverse health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0585-2026
Brand
Amneal Pharmaceuticals
Classification
Class III
Units affected
27,936 100-count bottles
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

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

Affected products

Companies & origin

Recalling firm location
Bridgewater, NJ, United States
Firm address
400 Crossing Blvd Fl 3, N/A, 08807-2863

Identifying details (verbatim from the notice)

Product codes / lots
Lot AM251676, EXP 11/31/2028
Distribution
Nationwide within the USA.
Firm notified the public via
Letter
FDA event ID
99146
Recall initiated
June 3, 2026
FDA classified
June 10, 2026
FDA report date
June 17, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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