Duloxetine Delayed-Release Capsules USP 60mg
Breckenridge Pharmaceutical recalls Duloxetine 60mg capsules (NDC 51991-748-90) due to elevated N-nitroso impurity from manufacturing deviations.
Do not use this medication. Contact Breckenridge Pharmaceutical or your healthcare provider for guidance on obtaining a replacement or alternative treatment. Return the product to your pharmacy or follow the firm's instructions for safe disposal.
Why it was recalled
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
How to identify it
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.
Where it was sold
Distributed in US.
Official source
Editorial summary by Recall Canary · last updated 2026-05-07 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification