Recall: D-0582-2026

Class II - Potentially Harmful

Class IIClassification

2026-06-04Initiated

OngoingStatus

Breckenridge Pharmaceutical, IFirm

Product

Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10

Reason

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