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FDAMarch 5, 2025drug

Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

rising pharma holdingrisingrising pharma

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99 — Recall Details · AllClear