Ajanta Pharma USA Inc

FDA Regulatory Profile

Ajanta Pharma USA Inc appears in FDA public data with 2 recalls, 0 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0611-2026, Class II) was initiated on May 28, 2026.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0611-2026Class IIFenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, IndMay 28, 2026
D-0594-2026Class IIAripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., BridgewatMay 27, 2026