Medications & Supplements/Prescription Drugs

Mylan Institutional, Inc. (d.b.a. UDL Laboratories): Alprazolam 0.25 mg Tablets Recalled for Elevated Impurity Levels

Agency Publication Date: March 20, 2019

Summary

Mylan Institutional, Inc. is recalling approximately 10,281 cartons of Alprazolam (the generic form of Xanax) 0.25 mg tablets due to elevated levels of a known chemical impurity. The issue was discovered during routine stability testing, which showed the tablets did not meet quality specifications over time. The affected products were sold in cartons containing 10 blister packs of 10 tablets each and were distributed nationwide across the United States and Puerto Rico.

Risk

The presence of impurities above the approved limit means the drug does not meet safety and quality standards, which could potentially lead to unexpected side effects or reduced medication effectiveness. No injuries or adverse reactions have been reported in connection with this recall.

What You Should Do

Check your medication packaging or prescription bottle to see if you have Alprazolam Tablets, USP, 0.25 mg with NDC number 51079-788-20.
Verify the lot numbers and expiration date on the side of the carton or individual blister packs; this recall specifically affects lots 3095198, 3096266, and 3098776 with an expiration date of 05-2019.
Contact your healthcare provider or pharmacist immediately for guidance on whether you should continue using your current supply or obtain a replacement.
Return any unused tablets from the affected lots to the pharmacy where you purchased them to receive a refund.
Contact the manufacturer, Mylan Institutional, Inc., for further instructions on returning the product or to report any concerns.
If you have 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

Refund or replacement via healthcare provider/pharmacy

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, 0.25 mg (10x10 per carton)

Model:

NDC: 51079-788-20

Recall #: D-1013-2019

Lot Numbers:

3095198

3096266

3098776

Date Ranges: EXP 05-2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81946

Status: Resolved

Manufacturer: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Sold By: Pharmacies; Hospitals

Manufactured In: United States

Units Affected: 10,281 UD 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 · 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 packaging or prescription bottle to see if you have Alprazolam Tablets, USP, 0.25 mg with NDC number 51079-788-20.

Verify the lot numbers and expiration date on the side of the carton or individual blister packs; this recall specifically affects lots 3095198, 3096266, and 3098776 with an expiration date of 05-2019.

Contact your healthcare provider or pharmacist immediately for guidance on whether you should continue using your current supply or obtain a replacement.

Return any unused tablets from the affected lots to the pharmacy where you purchased them to receive a refund.

Contact the manufacturer, Mylan Institutional, Inc., for further instructions on returning the product or to report any concerns.

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