FDA recall D-0511-2025

Product

Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.

Reason for recall

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

Distribution

U.S. Nationwide

Key facts

Status

Ongoing

Initiation date

2025-06-30

Report date

2025-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berkeley Heights, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0511-2025