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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 21, 2024
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Summary

Preferred Pharmaceuticals, Inc. has recalled 66 bottles of Duloxetine (Duloxetine Delayed-Release Capsules USP 30mg). The recall was initiated because tests found an impurity called N-nitroso-duloxetine at levels higher than the FDA's recommended limit. Duloxetine is a prescription medication used to treat conditions such as depression and anxiety. This recall affects 30-count bottles with lot number J2022G that were distributed in California, Florida, Oklahoma, Kansas, and Connecticut.

Risk

The capsules contain a nitrosamine impurity which is classified as a probable human carcinogen. While nitrosamines are common in water and foods, exposure to high levels over a long period may increase the risk of developing cancer.

What You Should Do

  1. This recall affects Preferred Pharmaceuticals, Inc. Duloxetine Delayed-Release Capsules USP 30mg, sold in 30-count bottles.
  2. To identify if your medication is affected, check the label for NDC 68788-9301-03 and lot number J2022G with an expiration date of 01/01/2025.
  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 Preferred Pharmaceuticals, Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information regarding this recall.

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 (30-count bottle)
Variants: 30mg, Delayed-Release Capsule
Lot Numbers:
J2022G (Exp: 01/01/2025)
NDC:
68788-9301-03

Quantity: 66 bottles of 30 tablets; Rx only

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94648
Status: Active
Manufacturer: Preferred Pharmaceuticals, Inc.
Sold By: Pharmacies; Healthcare Providers
Manufactured In: United States
Units Affected: 66 bottles of 30 tablets
Distributed To: California, Florida, Oklahoma, Kansas, Connecticut
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.