Primidone Tablets 50 mg Recalled for API Cross-Contamination
Amerisource Health Services LLC is recalling Primidone Tablets 50 mg due to cross-contamination of the active ingredient with trace amounts of Acemetacin API. The recall affects 225,000 tablets distributed nationwide.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source indicates this is an FDA Class III recall. No illnesses or injuries are reported, and the contamination is described as trace amounts. Class III recalls are by definition unlikely to cause adverse health consequences, warranting a Low severity score.
Plain-English summary
Amerisource Health Services LLC is recalling Primidone Tablets, USP, 50 mg (100 tablets per carton) distributed nationwide because the active pharmaceutical ingredient (API) has been contaminated with trace amounts of Acemetacin API due to cross-contamination during manufacturing.
The affected product includes Lot 1028739 (expiration 12/31/2027) and Lot 1025622 (expiration 06/30/2027). The carton NDC is 68084-202-01 and the individual dose NDC is 68084-202-11. A total of 225,000 tablets have been distributed.
Patients taking this medication should contact their healthcare provider if they have any concerns. Do not stop taking Primidone without consulting a healthcare professional, as it is used to treat seizure disorders and stopping abruptly could be harmful.
The recalled product
- Product
- PRIMIDONE (PRIMIDONE)
- Brand
- PRIMIDONE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Prescription / Oral
- Hazard
- cross-contamination
- api-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot 1028739
- exp 12/31/2027
- Lot 1025622
- exp 06/30/2027
Distribution
Distributed nationwide across the United States.