Quick Facts at a Glance
- Recall Date
- May 1, 2026
- Hazard Level
- HIGH
- Brands
- PRIMIDONE, American Health Packaging
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- PRIMIDONE, American Health Packaging
- Model numbers
- Lot 1028739, exp 12/31/2027, Lot 1025622, exp 06/30/2027
- UPC codes
- 68084-202, 68084-203, 68084-203-11, 68084-203-01, 68084-202-11, 68084-202-01
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 1, 2026
Reported by FDA DRUG
May 27, 2026
RecallRadar source check
June 3, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Amerisource Health Services LLC or your healthcare provider for guidance. Notification method: Letter
Get instant alerts for PRIMIDONE recalls
Be the first to know. Free instant alerts to your inbox.
Full Description
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11. Generic: PRIMIDONE; Brand: PRIMIDONE. Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.. Classification: Class III. Quantity: 225,000 tablets. Distribution: USA Nationwide
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
Get instant alerts for recalls that affect you. Free forever.