FDA recall D-0621-2025

Product

Duloxetine Delayed-Release Capsules, USP, 30 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: 82009-030-10

Reason for recall

CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

Distribution

AZ, IN, NJ

Key facts

Status

Ongoing

Initiation date

2025-08-08

Report date

2025-09-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berkeley Heights, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0621-2025