Upsher Smith Laboratories, Inc. recalls Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove,
Upsher Smith recalls 2mg Bumetanide tablets due to failed impurities causing potential safety issues. Affected lots expire 3/31/2020 or 5/31/2020. Check your NDC number for recall.
Recall notice
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Contact the company & request your remedy
What happened, in plain English
Upsher Smith is recalling 2mg Bumetanide tablets that failed impurity tests. This could pose safety risks if the tablets degrade, though the exact danger isn't specified in the recall notice. Read more at govinfonow.com/recall/39561-upsher-smith-bumetanide-tablets-recall-failed-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39561-upsher-smith-bumetanide-tablets-recall-failed-impurities-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-0281-2019
Cite this page
“Upsher Smith Bumetanide Tablets Recall: Failed Impurities Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39561-upsher-smith-bumetanide-tablets-recall-failed-impurities-risk. Based on FDA recall #D-0281-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0281-2019%22&limit=1).
Why it’s dangerous
The tablets failed impurity and degradation tests, meaning they may contain harmful substances. This could lead to safety issues if the tablets degrade over time, but the exact risk isn't detailed in the recall.
Who’s affected
Prescription patients who own the recalled 100-count bottles of Bumetanide tablets. Those with specific lot numbers from the recall list are most at risk.
How to tell if you have this one
Check for the NDC number 0832-0542-11 on the bottle. Look for lot numbers 372461, 372952, 372954, 372955, 373624, 374539, 375719, 375721, or 376684. The expiration dates are 3/31/2020 or 5/31/2020.
- Brand
Upsher Smith- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide USA, Puerto Rico and Guam- NDC
0832-0540-11, 0832-0541-11, 0832-0541-10, 0832-0542-11, 0832-0542-10
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0280-2019 | Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11; Lot#: 375716, Exp 4/30/2020; 372957, 372958, 372959, Exp 3/31/2020; 374541, 375717, 376688, Exp 5/31/2020 | 44,764 bottles |
| D-0281-2019 | Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11; Lot#: 372461, 372952, 372954, 372955, 373624, 374539, Exp 3/31/2020; 375719, 375721, 376684, Exp 5/31/2020 | 29,080 bottles |
What to do — step by step
Check Your Product
Look for the NDC number 0832-0542-11 and the listed lot numbers on the bottle.
Questions people ask
Why is this product being recalled?
The product failed impurity and degradation tests, meaning it may contain harmful substances.
What should I do if I have the recalled product?
The recall notice does not specify a remedy, so you should contact Upsher Smith for guidance.
How can I tell if my product is recalled?
Check for the NDC number 0832-0542-11 and lot numbers listed in the recall notice.
Contact Upsher Smith
We’ve drafted a message you can send Upsher Smith to request your refund or repair — edit it as you like.
Subject: Recall D-0281-2019 — Upsher Smith Upsher Smith Hello, I own a Upsher Smith that is covered by recall D-0281-2019 from Upsher Smith. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0281-2019 (September 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0281-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.