FDAClass II · Drug · Recalled June 24, 2026

Aripiprazole Tablets USP recall — Ajanta Pharma USA Inc

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0594-2026
Brand: Ajanta Pharma USA
Classification: Class II
Units affected: 6,143 bottles
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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.

Affected products

Aripiprazole Tablets USP

Companies & origin

Recalling firm location: Bridgewater, NJ, United States
Firm address: 400 Crossing Blvd Ste 102, 08807-2863

Identifying details (verbatim from the notice)

Product codes / lots: Lot: PA00805, expires: 01/31/2029
Distribution: U.S. Nationwide
Firm notified the public via: Letter
FDA event ID: 99046
Recall initiated: May 27, 2026
FDA classified: June 16, 2026
FDA report date: June 24, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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