Reported Jan 1, 2025 · Terminated

DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127,…

PD-Rx Pharmaceuticals, 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: PD-Rx Pharmaceuticals, Inc. · 727 N Ann Arbor Ave · Oklahoma City, OK · 73127-5822

Is this the product you have?

  • DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only
  • Packaged byPD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127
  • NDC43063-877-90
Lot codes and dates
    • Lot # I24E77
    • A24E49
  • Exp Date
    • 04/30/25
    • J23C50
    • J23C97
    • L23B39
    • L23E98
  • Exp Date01/31/2025
Amount recalled
70, 90-count bottles

Where it was sold

Why it was recalled

CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake 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

Notice updated Mar 21, 2025 · Data as of Sep 19, 8:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.