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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 AM251676, EXP 11/31/2028
Where it was soldNationwide within the USA.
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: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

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 byAmneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 foreign manufacturer
Brand namePRIMIDONE
Generic namePRIMIDONE
Active ingredient(s)PRIMIDONE
Distributed by / forAmneal Pharmaceuticals LLC, Bridgewater, NJ 08807
NDC53746-544-01
Show the full FDA record
Full product labelPrimidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
Recalling firmAmneal Pharmaceuticals, LLC
DistributionNationwide within the USA.
Quantity27,936 100-count bottles
Recall initiated2026-06-03
Report date2026-06-17
Recall completed—
Recall numberD-0585-2026
ClassificationClass III
FDA statusOngoing
Origin on fileBridgewater NJ 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.