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Breckenridge Pharmaceutical, Inc.: Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona),

DrugsSource: FDA (drug) · Date: 2026-05-13

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Breckenridge Pharmaceutical, Inc.
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 / hazard
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2026-04-21
Code info
Lot: 241069C, Exp 05/31/2027
Product quantity
165,761 90-count bottles
Voluntary mandated
Voluntary: Firm initiated
City
Berkeley Heights
State
NJ
Country
United States
Event id
98803
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