FDA recall, , Low risk
American Health Packaging Primidone Tablets
Primidone Tablets are contaminated with trace amounts of Acemetacin API, which can cause cross contamination.
Summary by Recall Canary from the FDA notice
What happened
Amerisource Health Services LLC, of Columbus, Ohio, recalled Primidone Tablets, USP, in 50 mg and 250 mg strengths, distributed by American Health Packaging, after the FDA reported cross contamination with other products: API contaminated with trace amounts of Acemetacin API. The recall began May 1, 2026, was added to the FDA's Enforcement Report and classified on May 18, 2026, and was in the FDA's weekly enforcement report on May 27, 2026. The products were distributed nationwide in the USA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its lot code and NDC are listed under that product.
An NDC (National Drug Code) is usually printed on the drug's label.
Primidone Tablets, USP
- Strength
- 50 mg
- NDC
- 68084-202-01
- 68084-202-11
- Lot code
- 1028739
- 1025622
- Strength
- 250 mg
- NDC
- 68084-203-01
- 68084-203-11
- Lot code
- 1027583
Recall details
- Company began the recall
- Sold in
USA Nationwide
- Company
- Amerisource Health Services LLCColumbus, Ohio
- Hazard
- Contamination
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98884
- Recall numbers
- D-0536-2026 to D-0537-2026
All recalls from Amerisource Health Services LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
