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Unrated Drug recall · FDA · Published November 6, 2013

Sandoz Recalls Bumetanide Tablets Due to Moisture Issues

Sandoz recalls specific lots of Bumetanide Tablets USP 0.5 mg due to failed moisture limits. Check your bottle's lot number and NDC for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-341-2014DrugSandoz ›
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Contact the company

Recalling firmSandoz Inc4700 Sandoz Dr · Wilson, NC 27893-8143
✎ GovInfoNow plain-language explainer

Sandoz Inc. is recalling specific lots of Bumetanide Tablets USP 0.5 mg because stability testing showed the moisture content exceeded specifications. The affected products are available in 100-count and 500-count bottles distributed nationwide. No remedy or action steps are currently listed in the recall record. Read more at govinfonow.com/recall/46428-sandoz-inc-recalls-bumetanide-tablets-usp-0-5-mg-rx.

Source Summary by GovInfoNow · govinfonow.com/recall/46428-sandoz-inc-recalls-bumetanide-tablets-usp-0-5-mg-rx · Updated October 13, 2026 · FDA enforcement record: FDA #D-341-2014

Cite this page

“Sandoz Recalls Bumetanide Tablets Due to Moisture Issues.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/46428-sandoz-inc-recalls-bumetanide-tablets-usp-0-5-mg-rx. Based on FDA recall #D-341-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-341-2014%22&limit=1).

The FDA announced on 2013-11-06 that Sandoz Inc voluntarily recalled Bumetanide Tablets USP 0.5 mg due to failed moisture limits, according to GovInfoNow's records.

How to tell if you have it

  • Brand: Sandoz
  • Product: Bumetanide Tablets USP 0.5 mg
  • NDC a) 0185-0128-01 (100-count Bottle), Lot #: CU6131
  • NDC b) 0185-0128-05 (500-count Bottle), Lot #: CW1161

The hazard

Out of Specification results were obtained for moisture content during stability testing at the 12 month time point under controlled room temperature conditions, according to the FDA.

Context

GovInfoNow's records show Sandoz Inc has 29 other recalls on record since 2013-10-09. Other recent recalls of similar products include Rising Pharma Recalls Temozolomide 5mg Capsules Due to Impurity Issues (2026-03-03), Unichem Bisoprolol/Hydrochlorothiazide Tablets Recall: N-Nitroso Impurity Risk (2026-01-21), and Synjardy XR Tablets Recall: Incorrect Detergent Used in Manufacturing (2026-06-12).

How to tell if you have this one

Check if you have Bumetanide Tablets USP 0.5 mg manufactured by Sandoz Inc. Look for NDC numbers 0185-0128-01 (100-count bottle) or 0185-0128-05 (500-count bottle). Affected lot numbers are CU6131 and CW1161.

  • Brand
    Sandoz
  • Category
    Drug

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 7 months after the firm started it.

1. Firm started the recall: Nov 6, 201312. FDA classified it Class III: Dec 6, 201323. Published in FDA’s Enforcement Report: Dec 18, 201334. FDA terminated the recall: May 29, 2014420132014
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-341-2014 (November 6, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-341-2014 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA