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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

Mylan Pharmaceuticals Inc.: Prasugrel Tablets Recalled for Failed Dissolution Specification

Agency Publication Date: October 28, 2019
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Summary

Mylan Pharmaceuticals Inc. is recalling 4,272 bottles of Prasugrel (5 mg) tablets, a prescription medication used to prevent blood clots. The recall was initiated because the tablets failed dissolution testing, meaning they may not dissolve properly in the body to release the medicine as intended. This defect could result in a lower-than-intended dose of the medication, which may reduce its effectiveness in preventing serious cardiovascular events. These tablets were distributed nationwide in the United States in 30-count bottles.

Risk

The tablets failed to meet the required dissolution specifications, which means the drug may not be absorbed by the body at the correct rate or amount. This poses a risk that patients may not receive the full therapeutic benefit of the medication, potentially increasing the risk of blood clots or other heart-related complications.

What You Should Do

  1. Check your prescription bottle to see if it is Prasugrel Tablets 5 mg, 30-count bottles, with NDC 0378-5185-93.
  2. Verify if your bottle belongs to Lot 3089793 with an expiration date of September 2020.
  3. Contact your healthcare provider or pharmacist immediately to discuss if you have been taking the affected medication and to obtain a replacement prescription.
  4. Do not stop taking your prescribed medication without first consulting a healthcare professional, as stopping blood-thinning medication abruptly can pose serious health risks.
  5. Return any unused product from the affected lot to your pharmacy for a refund.
  6. Contact Mylan Pharmaceuticals Inc. at 1-888-723-3332 for further instructions regarding this recall.
  7. For additional questions or to report adverse effects, 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

Healthcare consultation and pharmacy refund

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

Affected Products

Product: Prasugrel Tablets 5 mg (30-count bottle)
Model:
NDC 0378-5185-93
Lot Numbers:
3089793 (Exp. Date September 2020)
Date Ranges: Expiration Date: September 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84039
Status: Resolved
Manufacturer: Mylan Pharmaceuticals Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 4,272 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 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.