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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Duloxetine Delayed-Release Capsules Recalled for Nitrosamine Impurity

Agency Publication Date: May 4, 2024
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Summary

Breckenridge Pharmaceutical, Inc. is recalling 570,296 bottles of Duloxetine Delayed-Release Capsules (20mg, 30mg, and 60mg) because they contain an impurity called N-nitroso-duloxetine at levels higher than the FDA's recommended limit. Duloxetine is a prescription medication used to treat depression, anxiety, and certain types of nerve and muscle pain. Consumers should continue taking their medication until they speak with a doctor or pharmacist, as stopping suddenly can cause health issues.

Risk

The capsules contain N-nitroso-duloxetine, which is a type of nitrosamine impurity. Nitrosamines are classified as probable human carcinogens, meaning that long-term exposure to levels above the safety limit may increase the risk of developing cancer.

What You Should Do

  1. This recall affects Duloxetine Delayed-Release Capsules in 20mg, 30mg, and 60mg strengths sold under the Breckenridge Pharmaceutical, Inc. label in 90, 500, and 1,000-count bottles.
  2. Identify your medication by checking the NDC numbers 51991-746-05, 51991-747-90, 51991-747-10, or 51991-748-90 and looking for specific lot numbers and expiration dates on the bottle. See the Affected Products section below for the full list of affected codes.
  3. 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. directly for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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, 30mg
Variants: 30mg, Delayed-Release Capsule
Lot Numbers:
220265 (Exp. Feb 2025)
220088 (Exp. Nov 2024)
220267 (Exp. Feb 2025)
220256 (Exp. Feb 2025)
220225 (Exp. Jan 2025)
220269 (Exp. Feb 2025)
NDC:
51991-747-90
51991-747-10

Distributed in 90-count and 1,000-count bottles.

Product: Duloxetine Delayed-Release Capsules, USP, 20 mg
Variants: 20mg, Delayed-Release Capsule
Lot Numbers:
220456 (Exp. Feb 2025)
NDC:
51991-746-05

Distributed in 500-count bottles.

Product: Duloxetine Delayed-Release Capsules, USP, 60 mg
Variants: 60mg, Delayed-Release Capsule
Lot Numbers:
230028C (Exp. Nov 2025)
230106C (Exp. Dec 2025)
230170C (Exp. Dec 2025)
220039 (Exp. Dec 2024)
220363 (Exp. Feb 2025)
NDC:
51991-748-90

Distributed in 90-count bottles.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94483
Status: Active
Manufacturer: Breckenridge Pharmaceutical, Inc
Sold By: Retail Pharmacies; Hospitals
Manufactured In: Spain
Units Affected: 3 products (281,554/90 & 1000 count bottles; 7,188/ 500 count bottles; 281,554/90 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 ยท 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.