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Drug FDA Class III Ongoing Chemical

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

Amerisource Health Services LLC Published May 27, 2026

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 48/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Amerisource Health Services LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Hazards

Acemetacin API contamination · primary

Affected products (1)

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

PRIMIDONE · 63,500 tablets

NDC: 68084-202, 68084-203, 68084-203-11, 68084-203-01, 68084-202-11, 68084-202-01
Code info: Lot#: 1027583, Exp 09/30/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    May 1, 2026
  2. Published
    May 27, 2026
Recall number
D-0536-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.