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Breckenridge Pharmaceutical, Inc.: Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelle

DrugsSource: FDA (drug) · Date: 2026-06-17

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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, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
Reason / hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the United States
Recall initiated
2026-06-04
Code info
Lot: 241180C, Exp. Date April 2027.
Product quantity
14,729 bottles.
Voluntary mandated
Voluntary: Firm initiated
City
Berkeley Heights
State
NJ
Country
United States
Event id
99108
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