Medications & Supplements/Prescription Drugs

The Harvard Drug Group: Alprazolam 0.25 mg Tablets Recalled for Unknown Impurity

Agency Publication Date: October 17, 2017

Summary

The Harvard Drug Group has recalled approximately 3,935 cartons of Alprazolam (Xanax) 0.25 mg Tablets. This prescription medication is being recalled because testing revealed an unknown impurity that does not meet safety and quality standards. This recall affects the 100-count unit dose cartons distributed nationwide by Major Pharmaceuticals and Actavis Pharma.

Risk

The presence of an unknown impurity or degradation product means the drug may not perform as intended or could potentially cause unexpected side effects, though no specific adverse events have been reported for this lot.

What You Should Do

Check your medication packaging for Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose cartons with NDC 0904-5858-61.
Verify the specific lot and expiration date: Look for Lot 1274C151A with an expiration date of 10/17.
If you identify this lot in your possession, contact your healthcare provider or pharmacist immediately to discuss a replacement and for guidance on your treatment.
Return any unused portions of the recalled medication to the pharmacy where you purchased it for a refund.
Contact The Harvard Drug Group or the distributor, Major Pharmaceuticals, at 17177 N Laurel Park Dr Ste 233, Livonia, Michigan, for further instructions regarding this recall.
For additional questions or to report a problem, 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

Contact healthcare provider and return product for refund.

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 (100-count Unit Dose tablets per carton)

Model:

NDC 0904-5858-61

Lot Numbers:

1274C151A (Exp 10/17)

Date Ranges: Expiration 10/17

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78162

Status: Resolved

Manufacturer: The Harvard Drug Group

Sold By: Major Pharmaceuticals; Actavis Pharma, Inc.

Manufactured In: India, United States

Units Affected: 3,935 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 for Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose cartons with NDC 0904-5858-61.

Verify the specific lot and expiration date: Look for Lot 1274C151A with an expiration date of 10/17.

If you identify this lot in your possession, contact your healthcare provider or pharmacist immediately to discuss a replacement and for guidance on your treatment.

Return any unused portions of the recalled medication to the pharmacy where you purchased it for a refund.

Contact The Harvard Drug Group or the distributor, Major Pharmaceuticals, at 17177 N Laurel Park Dr Ste 233, Livonia, Michigan, for further instructions regarding this recall.

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