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Serious riskFDA DrugClass II

Ajanta Pharma aripiprazole tablets recalled for voriconazole mix-up

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.

From the FDA notice · Read the official notice ↗ · All Ajanta Pharma recalls

What to do

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

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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.
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Units affected
6,143 bottles
Illnesses reported
None reported
Manufactured in
400 Crossing Blvd Ste 102, Bridgewater, NJ, United States
Classification
Class II
Recall number
D-0594-2026

In the FDA's words

Description
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. Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg. Lot: PA00805, expires: 01/31/2029 Distribution: U.S. Nationwide Affected quantity: 6,143 bottles
Hazard
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.

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