PD-Rx Pharmaceuticals DULoxetine DR Recall: FDA Class II

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

Product description

DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90

Lot numbers, UPCs & expiration codes

Lot # I24E77, A24E49, Exp Date: 04/30/25; J23C50, J23C97, L23B39, L23E98, Exp Date: 01/31/2025

Where it was sold

Distributed within US: FL, MS, WI

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0163-2025
Classification: Class II
Status: Terminated
Recall initiated: Dec 4, 2024
FDA report date: Jan 1, 2025
Quantity: 70, 90-count bottles
Recall type: Voluntary: Firm initiated
Recalling firm: PD-Rx Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-0163-2025, exactly as published.

Show all FDA fields

City: Oklahoma City
State: OK
Status: Terminated
Country: United States
Event ID: 95922
Address: 727 N Ann Arbor Ave
Code information: Lot # I24E77, A24E49, Exp Date: 04/30/25; J23C50, J23C97, L23B39, L23E98, Exp Date: 01/31/2025
Postal code: 73127-5822
Report date: Jan 1, 2025
Product type: Drugs
Recall number: D-0163-2025
Classification: Class II
Recalling firm: PD-Rx Pharmaceuticals, Inc.
Product quantity: 70, 90-count bottles
Termination date: Mar 21, 2025
Reason for recall: CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
Voluntary / mandated: Voluntary: Firm initiated
Product description: DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
Distribution pattern: Distributed within US: FL, MS, WI
Recall initiation date: Dec 4, 2024
Initial firm notification: E-Mail
Center classification date: Dec 23, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0163-2025, published Jan 1, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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PD-Rx Pharmaceuticals DULoxetine DR Recall

Summary