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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:…

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 Medicine & devices FDA June 17, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
Amneal Pharmaceuticals, LLC — Bridgewater, NJ
Severity
Class III — low
Reported
June 17, 2026
Quantity
27,936 100-count bottles
Recall number
D-0585-2026
Status
Ongoing
Source
FDA

Where it went

Nationwide within the USA.

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