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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Mylan Pharmaceuticals Inc.: Triamterene and Hydrochlorothiazide Tablets Recalled for Subpotency

Agency Publication Date: July 12, 2018
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Summary

Approximately 28,436 bottles of Triamterene and Hydrochlorothiazide tablets (37.5 mg/25 mg) are being recalled because the medication was found to be subpotent. This defect means the tablets contain less of the active ingredient than they should, which can prevent the medication from working effectively to treat high blood pressure or fluid retention. The recall affects 100-count prescription bottles that were distributed nationwide within the United States.

Risk

Subpotent medication may lead to inadequate treatment of a patient's medical condition, such as uncontrolled high blood pressure or increased swelling (edema), because the patient is not receiving the full intended dose. While no specific injuries were reported, patients rely on these dosages for consistent health management.

What You Should Do

  1. Check your prescription bottle label to see if you have Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg in a 100-count size.
  2. Verify the identifying codes on the bottle: Look for NDC 0378-1352-01 and specifically for Lot number 2007979 with an expiration date of 11/30/2020.
  3. If your medication matches this lot, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking the medication.
  4. Return any unused tablets from the affected lot to the pharmacy where you purchased them for a refund.
  5. Contact the manufacturer, Mylan Pharmaceuticals Inc., for further instructions regarding this recall.
  6. For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

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

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

Affected Products

Product: Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg (100-count bottle)
Model:
NDC 0378-1352-01
Recall #: D-0978-2018
Lot Numbers:
2007979 (Exp. 11/30/2020)
Date Ranges: Expiration 11/30/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80454
Status: Resolved
Manufacturer: Mylan Pharmaceuticals Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 28,436 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 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.