United StatesDuloxetine Delayed‑Release Capsules, USP 60 mg in 90‑count bottles (NDC 51991‑748‑90, Lot 240721C, exp. 02/28/2027) and 1000‑count bottles (NDC 51991‑748‑10, Lot 230286C, exp. 02/28/2026), manufactured by Towa Pharmaceutical Europe and distributed by Breckenridge Pharmaceutical, sold nationwide in the U.S., are affected. The products were recalled for CGMP deviations after detection of N‑nitroso‑duloxetine impurity above the safety assessment limit of 12.5 ppm.
What's being recalled
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
Recalling firm: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ, United States.
How to identify it
90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026
The hazard
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)