FDA recall D-0522-2026

Product

Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.

Reason for recall

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2026-04-21

Report date

2026-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berkeley Heights, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0522-2026