FDA Drugs recall ·
Primidone Tablets USP, 250mg, 100-count bottle, Rx only… recall
- Recall number
- D-0533-2026
- Date
- (initiated April 24, 2026)
- Company / brand
- Lannett Company Inc.
1101 C Ave W, Seymour, IN, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 44865 bottles
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
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#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028.
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-0533-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.