Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
FDA recall notice · announced May 13, 2026 · 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, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
Reason for recall
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Notes
Distribution: Nationwide in the USA
Lot/code information: Lot: 241069C, Exp 05/31/2027
Quantity: 165,761 90-count bottles
Status: Ongoing
Products in this recall event:
- Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely (D-0522-2026)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.