FDA recall D-0515-2026

Product

Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03

Reason for recall

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Distribution

Nationwide within U.S

Key facts

Status

Ongoing

Initiation date

2026-04-29

Report date

2026-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Aurangabad, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0515-2026