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Class II · ModerateActive recall

Aripiprazole

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot: PA00805, expires: 01/31/2029
Where it was soldU.S. 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

Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.

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 byMade in India foreign manufacturer
Brand nameARIPIPRAZOLE
Generic nameARIPIPRAZOLE
Active ingredient(s)ARIPIPRAZOLE
Distributed by / forAjanta Pharma USA Inc
NDC27241-056-03
Show the full FDA record
Full product labelAripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.
Recalling firmAjanta Pharma USA Inc
DistributionU.S. Nationwide
Quantity6,143 bottles
Recall initiated2026-05-27
Report date2026-06-24
Recall completed—
Recall numberD-0594-2026
ClassificationClass II
FDA statusOngoing
Origin on fileBridgewater NJ United States

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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.