FDA Drugs recall ·
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per… recall
- Recall number
- D-0537-2026
- Date
- (initiated May 1, 2026)
- Company / brand
- Amerisource Health Services LLC
2550 John Glenn Ave Ste A, Columbus, OH, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 225,000 tablets
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
Distribution
USA Nationwide
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0537-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.