The Recall Desk
SevereFDA (Drugs)·D-0280-2019·Announced 2018-10-31

Upsher Smith Recalls Bumetanide Tablets for Unspecified Degradation Product

Upsher Smith is recalling Bumetanide tablets because the product failed impurity specifications for an unspecified degradation product.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric, as it may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Upsher Smith Laboratories, Inc. is recalling Bumetanide Tablets, USP, 1 mg, 100-count bottles. The recall involves 44,764 bottles distributed nationwide in the United States, Puerto Rico, and Guam. The affected lots are 375716, 372957, 372958, 372959, 374541, 375717, and 376688, with expiration dates ranging from March 31, 2020, to May 31, 2020.

The recall was initiated because the product is out of specification for an unspecified degradation product. This failure relates to impurities or degradation specifications required for the drug product.

Patients and healthcare providers should stop using the affected Bumetanide tablets and contact their healthcare provider for alternative treatment options. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
BUMETANIDE (BUMETANIDE)
Brand
BUMETANIDE
Manufacturer
Upsher Smith Laboratories, Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
44,764

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 (10)

  • Lot#: 375716
  • Exp 4/30/2020
  • 372957
  • 372958
  • 372959
  • Exp 3/31/2020
  • 374541
  • 375717
  • 376688
  • 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

Same manufacturer · Upsher Smith Laboratories, Inc.

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Same hazard · impurity

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