Information
Amerisource Health Services LLC Recalls Primidone Tablets
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0536-2026Drug / Pharmaceutical
Amerisource Health Services LLC Recalls Primidone Tablets
Amerisource Health Services LLC · Class III — Regulatory
Product Description
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
Reason for Recall
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
USA Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA has classified this as a Class III recall — the lowest severity level — for a pharmaceutical product recalled by Amerisource Health Services LLC on May 1, 2026. Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. This recall covers 63,500 tablets, distributed in USA Nationwide. Class III recalls typically involve products unlikely to cause health problems but that violate FDA manufacturing or labeling regulations.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.