← FDA ENFORCEMENT
D-0552-2025Class II

Breckenridge Pharmaceutical, Inc.

Recalling firm
Breckenridge Pharmaceutical, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-08-13
Distribution
U.S Nationwide
Firm state
NJ
Product quantity
1,829 60-count bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit

Product description

Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.

Code / lot info

Lot: 230836C, Exp.: 02/28/2026

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.