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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

AVKARE Inc.: Duloxetine Delayed-release Capsules Recalled for Elevated Phthalic Acid

Agency Publication Date: October 27, 2017
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Summary

AVKARE Inc. is recalling 274 cartons of Duloxetine Delayed-release Capsules USP, 20 mg (generic Cymbalta), a prescription medication used to treat depression and anxiety. This recall was initiated because testing found slightly elevated levels of phthalic acid, an impurity that failed to meet the required quality and degradation specifications. These products were distributed nationwide across the United States in unit-dose blister packs containing 50 capsules each.

Risk

The presence of elevated phthalic acid indicates the medication is degrading or contains impurities beyond safe pharmaceutical standards. This may reduce the effectiveness of the drug or expose patients to unintended chemical byproducts, though no specific injuries have been reported.

What You Should Do

  1. Locate your medication packaging and check for Duloxetine Delayed-release Capsules USP, 20 mg, sold in 50-count (5 x 10) unit-dose blister cartons.
  2. Verify the identifying details on the carton: check for Lot number 18103 with an expiration date of 11/18 (November 2018).
  3. Confirm the NDC (National Drug Code) on the package is 50268-283-15 and the UPC is 5026828311.
  4. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking the medication.
  5. Return any remaining unused capsules from lot 18103 to your pharmacy to receive a refund and ensure the product is properly handled.
  6. Contact AVKARE Inc. for further instructions regarding the return process or if you have questions about this recall.
  7. For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer for further instructions.

Affected Products

Product: Duloxetine Delayed-release Capsules USP, 20 mg (50 Capsules)
Model:
NDC 50268-283-15
Recall #: D-0055-2018
UPC Codes:
5026828311
Lot Numbers:
18103 (Exp. 11/18)
Date Ranges: Exp. 11/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78240
Status: Resolved
Manufacturer: AVKARE Inc.
Sold By: Pharmacies; Hospitals
Manufactured In: United States
Units Affected: 274 cartons
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 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.