Medications & Supplements/Prescription Drugs

Mylan Pharmaceuticals Inc.: Maxzide-25 Tablets Recalled for Superpotency

Agency Publication Date: June 14, 2018

Summary

Mylan Pharmaceuticals Inc. is recalling 1,620 bottles of Maxzide-25 (triamterene and hydrochlorothiazide) 37.5 mg / 25 mg tablets. This recall was initiated because routine testing found the medication to be "superpotent," meaning the tablets contain slightly more active ingredient than the specified limit. These prescription tablets are used to treat high blood pressure and fluid retention, and were distributed throughout the United States in 100-count bottles.

Risk

The tablets were found to have active ingredient levels slightly above the allowed specification, which could lead to an increased risk of side effects or unintended physiological responses associated with triamterene and hydrochlorothiazide. No specific injuries or adverse events have been reported to date.

What You Should Do

Check your medication bottle to see if you have Maxzide-25 (triamterene and hydrochlorothiazide) 37.5 mg / 25 mg tablets in 100-count bottles.
Verify if your bottle matches Lot Number 3087136 with an expiration date of 5/20 (May 2020).
Look for National Drug Code (NDC) 0378-0464-01 on the label to confirm the product is part of this recall.
Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if a replacement prescription is necessary.
Return any unused tablets from the affected lot to your pharmacy for a refund and to ensure proper disposal.
Contact Mylan Pharmaceuticals Inc. at their Morgantown, WV location if you have questions regarding the return process.
For additional information 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

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: Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg (100-count bottle)

Model:

NDC 0378-0464-01

Recall #: D-0877-2018

Lot Numbers:

3087136 (Exp 5/20)

Date Ranges: Expiration 5/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80261

Status: Resolved

Manufacturer: Mylan Pharmaceuticals Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 1,620 bottles

Distributed To: Nationwide

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

Risk

What You Should Do

Check your medication bottle to see if you have Maxzide-25 (triamterene and hydrochlorothiazide) 37.5 mg / 25 mg tablets in 100-count bottles.

Verify if your bottle matches Lot Number 3087136 with an expiration date of 5/20 (May 2020).

Look for National Drug Code (NDC) 0378-0464-01 on the label to confirm the product is part of this recall.

Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if a replacement prescription is necessary.

Return any unused tablets from the affected lot to your pharmacy for a refund and to ensure proper disposal.

Contact Mylan Pharmaceuticals Inc. at their Morgantown, WV location if you have questions regarding the return process.

For additional information 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.