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Drug FDA Class II Ongoing cGMP deviation

Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ

Rising Pharma Holding, Inc. Published Dec 11, 2024

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 DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ

233,003 bottles

Code info: a) 30s; DT6023059A, DT6023060A, DT6023065A, DT6023069A, DT6023070A, exp. date Jan-25, DT6023080A, exp. date Feb-25, DT6023093A, exp. date Mar-25, DTC24012A, exp. date Dec-25; b) 90s; DT6023108A, exp. date Apr-25, DTC23201A, exp. date Aug-25; c) 1000s; DT6022160A, DT6022165A, DT6022162A, DT6022164A, DT6022163A, DT6022171A, DT6022169A, DT6022170A, DT6022173A, exp. date Nov-24, DT6023009A, DT6023007A, DT6023008A, DT6023011A, DT6023034B, exp. date Dec-24, DT6023067C, exp. date Jan-25, DT6023114A, exp. date Apr-25, DTC23243A, exp. date Oct-25, DTC24040A, exp. date Dec-25

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 19, 2024
  2. Published
    Dec 11, 2024
Recall number
D-0107-2025
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.