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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

Sandoz Incorporated: Triamterene and Hydrochlorothiazide Tablets Recalled for Cross-Contamination

Agency Publication Date: April 16, 2018
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Summary

Sandoz Incorporated has recalled 11,680 bottles of Triamterene and Hydrochlorothiazide (75 mg/50 mg), a prescription medication used to treat high blood pressure and fluid retention. The recall was initiated because the tablets may be cross-contaminated with traces of other substances, including the blood pressure medication Lisinopril, as well as Mannitol, Iron, Calcium, and Phosphorous. These 500-count bottles were distributed nationwide across the United States and Puerto Rico.

Risk

The presence of unintended ingredients like Lisinopril or various minerals poses a risk of unexpected side effects or drug interactions, particularly for patients who may have sensitivities or specific medical conditions related to those substances.

What You Should Do

  1. Check your medication bottle for Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg in 500-count bottles with NDC 0781-5067-05.
  2. Verify if your bottle belongs to Lot # GW8264 or HD3095 with an expiration date of 12/18.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you should continue taking the medication or receive a replacement.
  4. Return any unused product from the affected lots to your pharmacy to receive a refund.
  5. Contact Sandoz Incorporated for further instructions regarding this recall or to report any concerns.
  6. 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

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy 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, 75 mg/50 mg (500-count bottles)
Model:
NDC 0781-5067-05
Lot Numbers:
GW8264 (Exp 12/18)
HD3095 (Exp 12/18)
Date Ranges: December 2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79788
Status: Resolved
Manufacturer: Sandoz Incorporated
Sold By: pharmacies
Manufactured In: United States
Units Affected: 11,680 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.