D-0594-2026Class II

Ajanta Pharma USA Inc

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2026-06-24

Distribution

U.S. Nationwide

Firm state

Product quantity

6,143 bottles

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

Reason for recall

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

Product 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.

Code / lot info

Lot: PA00805, expires: 01/31/2029

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.