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Primidone 50 mg Tablets
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DRUG RECALLLOW

Primidone 50 mg Tablets

Amneal Pharmaceuticals is recalling Primidone 50 mg tablets due to potential cross-contamination with Acemetacin API.

What to do

Consult your healthcare provider or pharmacist to determine if your medication is affected and to discuss alternative treatment options. Do not stop taking your medication without medical advice.

Posted
Updated
Agency
Firm
Amneal Pharmaceuticals, LLC
Recall ID
99146
Status
ONGOING

Why it was recalled

Amneal Pharmaceuticals is recalling specific lots of Primidone 50 mg tablets due to potential cross-contamination with Acemetacin API during the manufacturing process.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Primidone Tablets, USP

Strength
50 mg
NDC / UPC
NDC 53746-544-01

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Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification