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D-0594-2026Class II

Ajanta Pharma USA Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Ajanta Pharma USA Inc
Product type
Drug
Status
Ongoing
Report date
2026-06-24
Distribution
U.S. Nationwide
Firm state
NJ
Product quantity
6,143 bottles
Initiated by
Voluntary: Firm initiated
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

Data: U.S. FDA. 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. Open the enforcement explorer →