Medications & Supplements/Prescription Drugs

Duloxetine Delayed-Release Capsules Recalled for Nitrosamine Impurity

Agency Publication Date: July 9, 2025

Summary

Breckenridge Pharmaceutical, Inc. has issued a voluntary recall for 12,242 bottles of Duloxetine (40mg) Delayed-Release Capsules. The medication was found to contain N-nitroso-duloxetine, an impurity that exceeds the FDA's recommended interim safety limits. This prescription drug is commonly used to treat depression, anxiety, and certain types of chronic pain.

Risk

The impurity found in this medication is a nitrosamine, which is a substance that may increase the risk of cancer if consumers are exposed to it above acceptable levels over a long period of time.

What You Should Do

The recalled products are 30-count bottles of Duloxetine Delayed-Release Capsules, USP, 40mg, bearing NDC 51991-750-33 and Lot number 230199.
Check your prescription bottle label for Lot number 230199 with an expiration date of 01/31/2026.
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 Breckenridge Pharmaceutical, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding consumer safety.

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 Delayed-Release Capsules, USP (40mg)

Variants: 40mg, 30-count bottle, Rx Only

Lot Numbers:

230199 (Exp 01/31/2026)

NDC:

51991-750-33

Manufactured by Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Distributed by Breckenridge Pharmaceuticals, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97179

Status: Active

Manufacturer: Breckenridge Pharmaceutical, Inc.

Sold By: Retail pharmacies

Manufactured In: Spain, United States

Units Affected: 12,242 30-count bottles

Distributed To: Nationwide

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

The recalled products are 30-count bottles of Duloxetine Delayed-Release Capsules, USP, 40mg, bearing NDC 51991-750-33 and Lot number 230199.

Check your prescription bottle label for Lot number 230199 with an expiration date of 01/31/2026.

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 Breckenridge Pharmaceutical, Inc. for further instructions.

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