Why it was recalled
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Product description
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Lot numbers, UPCs & expiration codes
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.
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-0533-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Apr 24, 2026
- FDA report date
- May 27, 2026
- Quantity
- 44865 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lannett Company Inc.
Original FDA data
Every field from FDA enforcement report D-0533-2026, exactly as published.
Show all FDA fields
- City
- Seymour
- State
- IN
- Status
- Ongoing
- Country
- United States
- Event ID
- 98791
- Address
- 1101 C Ave W
- Code information
- 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.
- Postal code
- 47274-3342
- Report date
- May 27, 2026
- Product type
- Drugs
- Recall number
- D-0533-2026
- Classification
- Class III
- Recalling firm
- Lannett Company Inc.
- Product quantity
- 44865 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, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Apr 24, 2026
- Initial firm notification
- Letter
- Center classification date
- May 18, 2026