← FDA ENFORCEMENT
D-0511-2025Class II

Breckenridge Pharmaceutical, Inc.

Recalling firm
Breckenridge Pharmaceutical, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-07-16
Distribution
U.S. Nationwide
Firm state
NJ
Product quantity
12,242 30-count bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Product description

Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.

Code / lot info

Lot # 230199, Exp. Date 01/31/2026

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

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.