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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 Prasugrel Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: March 17, 2025
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Summary

Mylan Pharmaceuticals Inc. has recalled three lots of Prasugrel Tablets (5 mg), a prescription medication used to prevent blood clots. The recall was issued because testing showed the tablets failed dissolution specifications, meaning the medicine may not dissolve properly in the body. If the drug does not dissolve at the required rate, it may not be fully absorbed, which could reduce its effectiveness in preventing serious cardiovascular events.

Risk

If the medication fails to dissolve and absorb correctly, patients may not receive the intended dose to prevent blood clots. This could lead to a higher risk of heart attack, stroke, or other serious blood-clotting issues in patients with heart conditions.

What You Should Do

  1. The recalled medication is Mylan Prasugrel Tablets, USP, 5 mg, sold in 30-count bottles under NDC 0378-5185-93.
  2. Check your medication bottle for lot numbers 3211073, 3211074, or 3211075, all of which have an expiration date of 4/30/2026.
  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 Mylan Pharmaceuticals Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 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: Prasugrel Tablets, USP, 5 mg (30-count bottle)by Mylan Pharmaceuticals Inc.
Variants: 5 mg, 30-count bottle, Tablet
Lot Numbers:
3211073 (Exp 4/30/2026)
3211074 (Exp 4/30/2026)
3211075 (Exp 4/30/2026)
NDC:
0378-5185-93

Rx only medication.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96369
Status: Active
Manufacturer: MYLAN PHARMACEUTICALS INC
Sold By: Pharmacies
Manufactured In: United States
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.