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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Olmesartan Medoxomil/Hydrochlorothiazide Tablets Recalled for Dissolution Failure

Agency Publication Date: January 16, 2019
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Summary

Teva Pharmaceuticals USA is recalling approximately 181,456 bottles of Olmesartan Medoxomil and Hydrochlorothiazide (40 mg/25 mg) tablets, a prescription medication used to treat high blood pressure. The recall was initiated because the tablets failed dissolution testing, which means the medication may not dissolve properly in the body to release the active ingredients as intended. This defect could potentially reduce the effectiveness of the blood pressure treatment. These products were distributed nationwide in 30-count and 90-count bottles and were manufactured in Israel.

Risk

The tablets failed to meet dissolution specifications, which can prevent the medication from being absorbed correctly by the body. This may lead to uncontrolled high blood pressure, increasing the risk of cardiovascular events like heart attack or stroke if the medication does not work as expected.

What You Should Do

  1. Check your prescription bottle for the product name 'Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg' and the brand Teva Pharmaceuticals.
  2. Verify the lot number and expiration date on your packaging. Affected 30-count bottles (NDC 0093-7617-56) include lot numbers 49O005, 49O006, 49O007, and 49O010 with an expiration date of 02/2019.
  3. Verify the lot number and expiration date for 90-count bottles (NDC 0093-7617-98), which include lot numbers 49O005, 49O009, and 49O010 with an expiration date of 02/2019.
  4. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking this medication.
  5. Return any unused or affected medication to your pharmacy for a refund and contact Teva Pharmaceuticals for further instructions.
  6. 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

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: Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg (30-count bottle)
Model:
NDC 0093-7617-56
Lot Numbers:
49O005 (Exp 02/2019)
49O006 (Exp 02/2019)
49O007 (Exp 02/2019)
49O010 (Exp 02/2019)
Date Ranges: Expiration 02/2019
Product: Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg (90-count bottle)
Model:
NDC 0093-7617-98
Lot Numbers:
49O005 (Exp 02/2019)
49O009 (Exp 02/2019)
49O010 (Exp 02/2019)
Date Ranges: Expiration 02/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81840
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Pharmacies
Manufactured In: Israel, United States
Units Affected: 181,456 bottles
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 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.