FDA recall D-0580-2025

Product

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10

Reason for recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Distribution

NJ, AZ, IN

Key facts

Status

Ongoing

Initiation date

2025-07-25

Report date

2025-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berkeley Heights, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0580-2025