The Recall Desk
ModerateFDA (Drugs)·D-0281-2019·Announced 2018-10-31

Upsher Smith Recalls Bumetanide Tablets for Unspecified Degradation Product

Upsher Smith Laboratories is recalling 29,080 bottles of Bumetanide 2 mg tablets because the product failed impurity specifications for an unspecified degradation product.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Upsher Smith Laboratories, Inc. is recalling 29,080 bottles of Bumetanide Tablets, USP, 2 mg, 100-count. The recall is due to the product being out of specification for an unspecified degradation product. The affected product is a prescription-only medication manufactured by Upsher-Smith Laboratories, LLC, in Maple Grove, MN.

The recall covers specific lots with expiration dates of 3/31/2020 and 5/31/2020. The affected lot numbers are 372461, 372952, 372954, 372955, 373624, 374539, 375719, 375721, and 376684. The product was distributed nationwide in the USA, Puerto Rico, and Guam.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or supplier for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
BUMETANIDE (BUMETANIDE)
Brand
BUMETANIDE
Manufacturer
Upsher Smith Laboratories, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
29,080

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • Lot#: 372461
  • 372952
  • 372954
  • 372955
  • 373624
  • 374539
  • Exp 3/31/2020
  • 375719
  • 375721
  • 376684
  • Exp 5/31/2020

UPCs (2)

  • 0308320540115
  • 0308320541112

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Upsher Smith Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · BUMETANIDE

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Same hazard · impurity

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