May 2026 FDA Recall Aripiprazole by Ajanta Pharma Usa Inc
D-0594-2026 - Product Mix-Up
This Class II drug recall was voluntarily initiated by Ajanta Pharma Usa Inc on May 27, 2026 for the product Aripiprazole. The FDA reported the reason for recall as product mix-up. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0594-2026
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
05-27-2026
06-24-2026
6,143 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ajanta Pharma USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# Lot: PA00805, expires: 01/31/2029
