FDA recall D-0555-2026

Product

Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.

Reason for recall

CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2026-05-14

Report date

2026-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Torrance, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0555-2026