United StatesDuloxetine Delayed‑Release Capsules, USP — 30 mg (NDC 51991‑747‑10, 1000‑capsule bottles) and 60 mg (NDC 51991‑748‑90, 90‑capsule bottles; NDC 51991‑748‑10, 1000‑capsule bottles) distributed by Breckenridge Pharmaceuticals and manufactured by Towa are recalled. Affected lots include 30 mg lot 241180C (exp. Apr 2027) and 60 mg lots 241074C (exp. May 2027); 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413 (exp. Feb 2027); 240316 (exp. Jan 2027); 232311 (exp. Nov 2026); 240978C and 241052C (exp. Apr 2027). The recall is for CGMP deviations: presence of N‑nitroso‑duloxetine impurity above the FDA’s recommended interim limit; products were sold nationwide in the U.S.
What's being recalled
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
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Recalling firm: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ, United States.
How to identify it
Lot: 241180C, Exp. Date April 2027. Lot: a) 241074C, Exp. Date May 2027; 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, Exp. Date February 2027; 240316,Exp. Date January 2027; 232311, Exp. Date November 2026; b) 240978C, 241052C, Exp. Date April 2027.
The hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
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
Nationwide within the United States
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)