Recall: D-0580-2025

Class II - Potentially Harmful

Class IIClassification

2025-07-25Initiated

OngoingStatus

Breckenridge Pharmaceutical, IFirm

Product

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10

Reason

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

Distribution

NJ, AZ, IN

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