FDA Drugs recall ·
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only… recall
- Recall number
- D-0535-2026
- Date
- (initiated April 27, 2026)
- Company / brand
- Golden State Medical Supply Inc.
5187 Camino Ruiz, Camarillo, CA, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 1,620 bottles
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01
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 #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026
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-0535-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.