FDARecalled June 3, 2026Class III

Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal P… Recalled: Cross Contamination with Other Products: due to a potential for cross-contamination with…

Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx… was recalled on June 3, 2026 in cooperation with the U.S. Food and Drug Administration because cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API…

Is my unit affected?

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

Model, lot & date codes to check

Lot AM251676, EXP 11/31/2028

Units affected: 27,936 100-count bottles

Where it was sold: Nationwide within the USA.

Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.

What's the 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 means the product is unlikely to cause a health problem, but it violates FDA labeling or manufacturing rules.

Your remedy & how to claim it

Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.

Contact: Recalling firm: Amneal Pharmaceuticals, LLC

Not sure what you're entitled to? Read our guide: what to do if your product is recalled.

Official recall notice

Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.

View official notice →

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Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal P… Recalled: Cross Contamination with Other Products: due to a potential for cross-contamination with…

Is my unit affected?

Model, lot & date codes to check

What's the hazard?

Your remedy & how to claim it

Official recall notice

Related recalls

Maple Leaf Foods Inc. Recalls Not Ready-To-Eat (NRTE) Bacon Product Imported without the Benefit of Import Reinspection

BCI Foods, Inc. Recalls Chicken Noodle Soup Product Imported without the Benefit of Import Reinspection

Madewell Recalls Women's Sweaters Due to Due to Risk of Serious Injury or Death from Burn Hazard; Violate Mandatory Standard for Clothing Textiles

FSIS Issues Public Health Alert for A Ready-To-Eat Beef Jerky Product Due to Misbranding and Undeclared Allergen

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