Medications & Supplements/Prescription Drugs

Mylan Pharmaceuticals Inc.: Alprazolam Tablets Recalled for Presence of Foreign Substance

Agency Publication Date: November 5, 2019

Summary

Mylan Pharmaceuticals Inc. has recalled 5,760 bottles of Alprazolam Tablets (0.5 mg), a medication commonly used to treat anxiety and panic disorders. The recall was initiated because of the presence of a foreign substance found within the product. Consumers should immediately check their prescription bottles to see if they are part of the affected batch and consult with a healthcare professional regarding their treatment.

Risk

The presence of a foreign substance in medication can pose a risk of injury or illness if ingested, as the substance is not part of the intended drug formulation.

What You Should Do

Check your medication bottle for Alprazolam Tablets, USP 0.5 mg in 500-count bottles with NDC 0378-4003-05.
Verify if your bottle belongs to Lot number 8082708 with an expiration date of September 2020.
If your medication matches this lot number, contact your healthcare provider or pharmacist for guidance before stopping the medication.
Return any unused product from the affected lot to your pharmacy for a refund.
Contact Mylan Pharmaceuticals Inc. at 781 Chestnut Ridge Rd, Morgantown, West Virginia for further instructions regarding this recall.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy refund and healthcare consultation

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

Affected Products

Product: Alprazolam Tablets, USP 0.5 mg (500-count bottle)

Model:

NDC 0378-4003-05

Recall #: D-0186-2020

Lot Numbers:

8082708 (Exp. Date September 2020)

Date Ranges: September 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84080

Status: Resolved

Manufacturer: Mylan Pharmaceuticals Inc.

Sold By: Pharmacies

Manufactured In: Australia, United States

Units Affected: 5,760 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 · 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.

Summary

What You Should Do

Check your medication bottle for Alprazolam Tablets, USP 0.5 mg in 500-count bottles with NDC 0378-4003-05.

Verify if your bottle belongs to Lot number 8082708 with an expiration date of September 2020.

If your medication matches this lot number, contact your healthcare provider or pharmacist for guidance before stopping the medication.

Return any unused product from the affected lot to your pharmacy for a refund.

Contact Mylan Pharmaceuticals Inc. at 781 Chestnut Ridge Rd, Morgantown, West Virginia for further instructions regarding this recall.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.