Medications & Supplements/Prescription Drugs

Breckenridge Duloxetine Delayed-Release Capsules Recalled for Impurity

Agency Publication Date: June 20, 2024

Summary

Breckenridge Pharmaceutical, Inc. is recalling 165,678 bottles of Duloxetine (the generic version of Cymbalta) Delayed-Release Capsules, USP, 60mg. The recall was initiated because tests detected an impurity called N-nitroso-duloxetine at levels above the safety limit recommended by the FDA. This medication was distributed nationwide in 90-count bottles.

Risk

The capsules contain a nitrosamine impurity that exceeds the FDA's recommended interim limit. Nitrosamines are classified as probable human carcinogens, meaning long-term exposure to these substances above certain levels may potentially increase the risk of cancer.

What You Should Do

This recall affects Duloxetine Delayed-Release Capsules, USP, 60mg, distributed by Breckenridge Pharmaceutical, Inc. in 90-count bottles with NDC 51991-748-90.
Check your medication bottle for lot number 230035C (Expiration date 11/30/2025) or lot number 230101C (Expiration date 12/31/2025).
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 questions.

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 (90-count bottle)

Variants: 60mg

Lot Numbers:

230035C (Exp 11/30/2025)

230101C (Exp 12/31/2025)

NDC:

51991-748-90

Rx Only. Manufactured by Towa Pharmaceutical Europe, S.L. in Spain.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94611

Status: Resolved

Manufacturer: Breckenridge Pharmaceutical, Inc

Sold By: Pharmacies

Manufactured In: Spain

Units Affected: 165,678, 90-count bottles

Distributed To: Nationwide

Agency Last Updated: October 31, 2024

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 Duloxetine Delayed-Release Capsules, USP, 60mg, distributed by Breckenridge Pharmaceutical, Inc. in 90-count bottles with NDC 51991-748-90.

Check your medication bottle for lot number 230035C (Expiration date 11/30/2025) or lot number 230101C (Expiration date 12/31/2025).

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 questions.