FDA recall D-0594-2026

Ajanta Pharma USA Inc · Class II · drug

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.

Reason for recall

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

Distribution

U.S. Nationwide

Key facts

Status
Ongoing
Initiation date
2026-05-27
Report date
2026-06-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0594-2026