FDA recall, , Low risk
Amneal Primidone Tablets
Primidone Tablets, USP, 50 mg may be cross-contaminated with Acemetacin API.
Summary by Recall Canary from the FDA notice
What happened
Amneal Pharmaceuticals, LLC of Bridgewater, New Jersey is recalling Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, due to a potential for cross-contamination with Acemetacin API caused by an issue at the API manufacturer. The product is distributed nationwide within the USA. The company began the recall on June 3, 2026, and the FDA added it to the Enforcement Report on June 10, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Primidone Tablets, USP, 50 mg
- NDC
- 53746-544-01
- Lot code
- AM251676
Recall details
- Company began the recall
- Sold in
Nationwide within the USA.
- Company
- Amneal Pharmaceuticals, LLCBridgewater, New Jersey
- Hazard
- Contamination
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 99146
- Recall number
- D-0585-2026
All recalls from Amneal Pharmaceuticals, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
