Ajanta Pharma Ltd.

FDA Regulatory Profile

Ajanta Pharma Ltd. appears in FDA public data with 3 recalls, 0 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0515-2026, Class II) was initiated on April 29, 2026.

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0515-2026Class IIDuloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA IncApril 29, 2026
D-0514-2026Class IIDuloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsuleApril 29, 2026
D-0516-2026Class IIDuloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA IncApril 29, 2026