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Class III · Lower riskActive recall

Primidone

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAmerican Health Packaging
Brand namePRIMIDONE
Generic namePRIMIDONE
Active ingredient(s)PRIMIDONE
Distributed by / forAmerican Health Packaging, Columbus, Ohio 43217. Carton
NDC68084-202-01
Show the full FDA record
Full product labelPrimidone 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
Recalling firmAmerisource Health Services LLC
DistributionUSA Nationwide
Quantity225,000 tablets
Recall initiated2026-05-01
Report date2026-05-27
Recall completed—
Recall numberD-0537-2026
ClassificationClass III
FDA statusOngoing
Origin on fileColumbus OH United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.