Recall: D-0522-2026

Class II - Potentially Harmful

Class IIClassification

2026-04-21Initiated

OngoingStatus

Breckenridge Pharmaceutical, IFirm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.