Medications & Supplements/Prescription Drugs

Duloxetine DR 30 mg Recalled for High Levels of Nitrosamine Impurity

Agency Publication Date: December 23, 2024

Summary

PD-Rx Pharmaceuticals, Inc. has recalled 70, 90-count bottles of Duloxetine DR USP (30 mg), a prescription medication used to treat depression, anxiety, and certain types of pain. The recall was issued because testing found levels of a nitrosamine impurity called N-Nitroso-Duloxetine that exceed the acceptable daily intake limits. This impurity is a substance that could potentially increase the risk of cancer over long-term exposure.

Risk

The product contains N-Nitroso-Duloxetine at levels higher than allowed by the FDA. Nitrosamines are common in water and foods, but exposure to high levels over a long period of time may increase the risk of cancer.

What You Should Do

This recall affects 90-count bottles of Duloxetine DR USP (30 mg) packaged by PD Rx Pharmaceuticals Inc (NDC 43063-877-90) with lot numbers I24E77, A24E49, J23C50, J23C97, L23B39, or L23E98.
Check the label on your prescription bottle for the lot number and expiration dates of 01/31/2025 or 04/30/2025 to determine if your medication is part of the recall.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: DULoxetine DR USP (30 mg)

Variants: 30 mg, 90-count bottle, Delayed-Release, Rx Only

Lot Numbers:

I24E77 (Exp 04/30/25)

A24E49 (Exp 04/30/25)

J23C50 (Exp 01/31/2025)

J23C97 (Exp 01/31/2025)

L23B39 (Exp 01/31/2025)

L23E98 (Exp 01/31/2025)

NDC:

43063-877-90

Packaged by PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95922

Status: Resolved

Manufacturer: PD-Rx Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 70, 90-count bottles

Distributed To: Florida, Mississippi, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects 90-count bottles of Duloxetine DR USP (30 mg) packaged by PD Rx Pharmaceuticals Inc (NDC 43063-877-90) with lot numbers I24E77, A24E49, J23C50, J23C97, L23B39, or L23E98.

Check the label on your prescription bottle for the lot number and expiration dates of 01/31/2025 or 04/30/2025 to determine if your medication is part of the recall.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: DULoxetine DR USP (30 mg)

Variants: 30 mg, 90-count bottle, Delayed-Release, Rx Only

Lot Numbers:

I24E77 (Exp 04/30/25)

A24E49 (Exp 04/30/25)

J23C50 (Exp 01/31/2025)

J23C97 (Exp 01/31/2025)

L23B39 (Exp 01/31/2025)

L23E98 (Exp 01/31/2025)

NDC:

43063-877-90

Packaged by PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127.