Reported Mar 26, 2025 · Ongoing

Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC,…

Rising Pharma Holding, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Rising Pharma Holding, Inc. · 2 Tower Center Blvd Ste 1401 · East Brunswick, NJ · 08816-1149

Is this the product you have?

  • Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only
  • Distributed byRising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Lot codes and dates
    • Lot #: DTB23111A
    • Exp 8/31/2025
Amount recalled
1223 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 4:18 PM UTC

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