Official recall notice
FDA DrugClass IIINotable
FDA Recall: Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceutic
- Recall date
- 2026-06-17
- Category
- Drug
- FDA class
- Class III
Why it was recalled
Hazard
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Recommended action
What to do
27,936 100-count bottles
Product description
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.