Recall: D-0552-2025

Class II - Potentially Harmful

Class IIClassification

2025-07-15Initiated

OngoingStatus

Breckenridge Pharmaceutical, IFirm

Product

Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.

Reason

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit

Distribution

U.S Nationwide

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