Class II

Drug Recall: 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

Breckenridge Pharmaceutical, Inc. · April 21, 2026

Reason for Recall

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

Product Description

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.

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

165,761 90-count bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0522-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.