Primidone 50 mg Tablets
Amneal Pharmaceuticals is recalling Primidone 50 mg tablets due to potential cross-contamination with Acemetacin API.
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.
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
- Lot code
- AM251676, 2028
- Strength
- 50 mg
- NDC / UPC
- NDC 53746-544-01
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Contamination recalls
Other recent recalls from Amneal Pharmaceuticals, LLC
Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification