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 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
Lot numbers, UPCs & expiration codes
Lot#: 1027583, Exp 09/30/2027
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-0536-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- May 1, 2026
- FDA report date
- May 27, 2026
- Quantity
- 63,500 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services LLC
Original FDA data
Every field from FDA enforcement report D-0536-2026, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 98884
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot#: 1027583, Exp 09/30/2027
- Postal code
- 43217-1188
- Report date
- May 27, 2026
- Product type
- Drugs
- Recall number
- D-0536-2026
- Classification
- Class III
- Recalling firm
- Amerisource Health Services LLC
- Product quantity
- 63,500 tablets
- 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 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
- Distribution pattern
- USA Nationwide
- Recall initiation date
- May 1, 2026
- Initial firm notification
- Letter
- Center classification date
- May 18, 2026