Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DULoxetine DR USP Recalled by PD-Rx Pharmaceuticals, Inc. Due to CGMP Deviations: the presence of a Nitrosamine Drug...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact PD-Rx Pharmaceuticals, Inc. directly.
Affected Products
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
Quantity: 70, 90-count bottles
Why Was This Recalled?
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
Where Was This Sold?
This product was distributed to 3 states: FL, MS, WI
About PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc. has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report