FDA-Drug2026-06-24Class IIMISBRANDING

Ajanta Pharma aripiprazole tablets recalled due to voriconazole product mix-up

LABEL MIX UPNationwide distribution

Ajanta Pharma aripiprazole recalled for wrong medication inside bottle

Ajanta Pharma USA Inc. distributed bottles labeled as Aripiprazole 30 mg that actually contained Voriconazole 50 mg, a different medication used to treat fungal infections. This mix-up affected 6,143 bottles (Lot PA00805, expiring 01/31/2029) distributed nationwide. The error was discovered and reported to the FDA.

  • If you have Aripiprazole 30 mg from Ajanta Pharma (NDC 27241-056-03, Lot PA00805), do not take it.
  • Contact your pharmacy or prescriber to verify you have the correct medication and obtain a replacement.
  • If you took any doses from this bottle, contact your doctor or poison control (1-800-222-1222) for guidance.
Hazard

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

Sold states
U.S. Nationwide
Affected count
6,143 bottles
Manufactured in
400 Crossing Blvd Ste 102, Bridgewater, NJ, United States
Products
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0594-2026

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