June 2026 FDA Recall Primidone by Amneal Pharmaceuticals, Llc
D-0585-2026 - Cross Contamination with Other Products
This Class III drug recall was voluntarily initiated by Amneal Pharmaceuticals, Llc on June 3, 2026 for the product Primidone. The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0585-2026
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
06-03-2026
06-17-2026
27,936 100-count bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Amneal Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot AM251676, EXP 11/31/2028
