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Recall

Amneal Pharmaceuticals, LLC: Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Recall

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

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Official-source record

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Agency
FDA
Record ID
D-0585-2026
Canonical
https://claimwatch-mvp.vercel.app/item/amneal-pharmaceuticals-llc-primidone-tablets-usp-50-mg-100-tablets-per-bottle-rx-only/

What happened?

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

Who may be affected?

Nationwide within the USA.

What should consumers do?

Affected quantity: 27,936 100-count bottles

Official source

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No. This page is informational. Always confirm eligibility, deadlines, and safety instructions through official sources.

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