← FDA ENFORCEMENT
D-0522-2026Class II

Breckenridge Pharmaceutical, Inc.

Recalling firm
Breckenridge Pharmaceutical, Inc.
Product type
Drug
Status
Ongoing
Report date
2026-05-13
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
165,761 90-count bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Product description

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.

Code / lot info

Lot: 241069C, Exp 05/31/2027

Other recalls SPEQ maps to Validation & Qualification
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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.