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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

West-Ward Columbus Inc: Ethacrynic Acid Tablets Recalled for Impurity and Degradation Issues

Agency Publication Date: May 21, 2020
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Summary

West-Ward Columbus Inc. has voluntarily recalled 3,336 bottles of Ethacrynic Acid Tablets USP (25 mg), a prescription diuretic medication. The recall was initiated because the tablets failed to meet quality specifications for "impurity 6" and total degradants, which means the product is breaking down faster than expected. Consumers who have these tablets should be aware that the medication may not perform as intended or could contain higher levels of impurities than permitted by safety standards.

Risk

The presence of excessive impurities or degradation products in medication can reduce the drug's effectiveness and potentially introduce chemical byproducts that have not been safety-tested at these higher levels. While this recall is classified as low risk, using out-of-specification medication may result in inadequate treatment for the underlying medical condition.

What You Should Do

  1. Locate your prescription bottle of Ethacrynic Acid Tablets USP, 25 mg (100 tablets per bottle) and check the label for NDC number 0054-0415-25.
  2. Identify if your bottle is affected by checking the lot information: Look for Lot Number AA4424A with an expiration date of 07/31/2020.
  3. If your medication matches Lot Number AA4424A, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription.
  4. Do not stop taking your medication without consulting a healthcare professional first, as abruptly stopping a prescribed diuretic can have health consequences.
  5. Return any remaining unused tablets from the affected lot to the pharmacy where you purchased them for a refund.
  6. Contact the manufacturer, West-Ward Columbus Inc. (also known as West-Ward Pharmaceuticals Corp.), for further instructions regarding the return process.
  7. 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: Ethacrynic Acid Tablets USP, 25 mg (100 Tablets per Bottle)
Model:
NDC: 0054-0415-25
Recall #: D-1282-2020
Lot Numbers:
AA4424A (Exp. 07/31/2020)
Date Ranges: Exp. 07/31/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85709
Status: Resolved
Manufacturer: West-Ward Columbus Inc
Sold By: West-Ward Pharmaceuticals Corp.
Manufactured In: United States
Units Affected: 3336 Bottles
Distributed To: Nationwide
Agency Last Updated: May 29, 2020

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.