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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Golden State Medical Supply Inc.
Reason for Recall:
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0535-2026

Related Recalls

Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.

May 29, 2026 Prescription Drugs View Details →