Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
FDA recall notice · announced August 13, 2025 · Breckenridge Pharmaceutical
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
Reason for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Notes
Distribution: U.S Nationwide
Lot/code information: Lot: 230836C, Exp.: 02/28/2026
Quantity: 1,829 60-count bottles
Status: Ongoing
Products in this recall event:
- Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, I (D-0552-2025)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.