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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

Upsher Smith Laboratories, Inc.: Bumetanide Tablets Recalled for Failed Impurity and Degradation Tests

Agency Publication Date: October 25, 2018
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Summary

Upsher-Smith Laboratories is recalling 73,844 bottles of Bumetanide Tablets (generic Bumex), a prescription diuretic medication, because testing found an unspecified degradation product that does not meet safety and quality standards. This recall affects 1 mg and 2 mg strengths in 100-count bottles sold nationwide, including Puerto Rico and Guam. Because the product is "out of specification," it may not maintain its intended potency or safety profile throughout its shelf life. Consumers who have these specific lots should contact their healthcare provider or pharmacist for guidance on continuing their treatment.

Risk

The tablets contain a degradation byproduct that exceeded acceptable purity limits, which could potentially impact the medication's effectiveness or lead to unexpected side effects. While no specific injuries have been reported, using a degraded medication means you may not be receiving the precise dose required to manage your condition.

What You Should Do

  1. Check your prescription bottle for Bumetanide Tablets, USP, 1 mg (100-count, NDC 0832-0541-11) and look for lot numbers: 375716 (Exp 4/30/2020); 372957, 372958, 372959 (Exp 3/31/2020); or 374541, 375717, 376688 (Exp 5/31/2020).
  2. Check your prescription bottle for Bumetanide Tablets, USP, 2 mg (100-count, NDC 0832-0542-11) and look for lot numbers: 372461, 372952, 372954, 372955, 373624, 374539 (Exp 3/31/2020); or 375719, 375721, 376684 (Exp 5/31/2020).
  3. If your medication is from an affected lot, contact your healthcare provider or pharmacist immediately to discuss a replacement or alternative treatment; do not stop taking your medication without professional advice.
  4. Return any unused product from the affected lots to your pharmacy for a refund and contact Upsher-Smith Laboratories at 1-888-723-3332 for further instructions.
  5. 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 consultation and pharmacy return

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

Affected Products

Product: Bumetanide Tablets, USP, 1 mg (100-count bottle)
Model:
NDC 0832-0541-11
Recall #: D-0280-2019
Lot Numbers:
375716 (Exp 4/30/2020)
372957 (Exp 3/31/2020)
372958 (Exp 3/31/2020)
372959 (Exp 3/31/2020)
374541 (Exp 5/31/2020)
375717 (Exp 5/31/2020)
376688 (Exp 5/31/2020)
Date Ranges: Expiration dates: 3/31/2020, 4/30/2020, 5/31/2020
Product: Bumetanide Tablets, USP, 2 mg (100-count bottle)
Model:
NDC 0832-0542-11
Recall #: D-0281-2019
Lot Numbers:
372461 (Exp 3/31/2020)
372952 (Exp 3/31/2020)
372954 (Exp 3/31/2020)
372955 (Exp 3/31/2020)
373624 (Exp 3/31/2020)
374539 (Exp 3/31/2020)
375719 (Exp 5/31/2020)
375721 (Exp 5/31/2020)
376684 (Exp 5/31/2020)
Date Ranges: Expiration dates: 3/31/2020, 5/31/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81174
Status: Resolved
Manufacturer: Upsher Smith Laboratories, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2 products (44,764 bottles; 29,080 bottles)
Distributed To: Nationwide
Agency Last Updated: November 21, 2018

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.