Why it was recalled
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Product 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
Lot numbers, UPCs & expiration codes
Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0535-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Apr 27, 2026
- FDA report date
- May 27, 2026
- Quantity
- 1,620 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-0535-2026, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 98856
- Address
- 5187 Camino Ruiz
- Code information
- Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026
- Postal code
- 93012-8601
- Report date
- May 27, 2026
- Product type
- Drugs
- Recall number
- D-0535-2026
- Classification
- Class III
- Recalling firm
- Golden State Medical Supply Inc.
- Product quantity
- 1,620 bottles
- Reason for recall
- Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Apr 27, 2026
- Initial firm notification
- Letter
- Center classification date
- May 18, 2026