Primidone Tablets recall: Contamination
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
Why was Primidone Tablets recalled?
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
- Product
- Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
- Recalling firm
- Amerisource Health Services LLC
- Quantity
- 225,000 tablets
- Distribution
- USA Nationwide
- Recall date
- May 27, 2026
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)