Duloxetine Delayed-Release Capsules recall (Breckenridge Pharmaceutical, Inc.)

DrugClass IIOngoing

Summary: Breckenridge Pharmaceutical, Inc. is recalling Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.. Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit.

What is being recalled

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.

Why

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

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Nationwide within the United States

How to tell if yours is affected

Lot #: 240947C, 240962C, Exp. Date 04/2027

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

More recalls from Breckenridge Pharmaceutical, Inc. · all drug recalls · recalls from November 2025

Official FDA record