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Drug FDA Class II Ongoing cGMP deviation

Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

Rising Pharma Holding, Inc. Published Jan 15, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Rising Pharma Holding, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

N-nitroso-duloxetine · primary

Affected products (1)

Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

73,680 bottles

Lot codes: DT2023003A
Code info: Lot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25

Affected areas

Nationwide

Timeline

  1. Initiated
    Dec 30, 2024
  2. Published
    Jan 15, 2025
Recall number
D-0189-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.