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Amneal Pharmaceuticals, LLC

Low risk

The FDA considers this unlikely to cause harm. Return it for a refund if you would rather not keep it.

Class III

  • Unlikely to cause any adverse health consequence, but the product breaks FDA rules.
  • Refunds don't require a receipt, and you don't need proof of purchase.
  • FDA status: Ongoing.

What was recalled

Source: FDA · synced 29 Jul 2026 13:14
Low risk Filed 2026-06-17

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

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

Check these codes: Lot AM251676, EXP 11/31/2028

27,936 100-count bottles · distributed nationwide within the usa. Recall D-0585-2026 on FDA.gov ↗
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