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FDARecalled May 13, 2026 · #D-0522-2026

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., Berk...

Hazard

Class II — temporary health risk

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Description

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Classification: Class II Distribution: Nationwide in the USA

Product details

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.
Type
Drugs
Manufacturer
Breckenridge Pharmaceutical, Inc.
Model numbers
241069C
UPCs