FDAClass IIIMay 27, 2026

Primidone Tablets recall: Contamination

Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11

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#: 1027583, Exp 09/30/2027

Product
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
Recalling firm
Amerisource Health Services LLC
Quantity
63,500 tablets
Distribution
USA Nationwide
Recall date
May 27, 2026
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
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