Recall: D-0216-2026

Class II - Potentially Harmful

Class IIClassification

2025-11-24Initiated

OngoingStatus

Breckenridge Pharmaceutical, IFirm

Product

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.

Reason

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

Distribution

Nationwide within the United States

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