Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Bumetanide Tablets Recalled by Upsher Smith Laboratories, Inc. Due to Failed impurities/ degradation specifications: Product is Out of...

Date: September 19, 2018
Company: Upsher Smith Laboratories, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Upsher Smith Laboratories, Inc. directly.

Affected Products

Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11

Quantity: 44,764 bottles

Why Was This Recalled?

Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Upsher Smith Laboratories, Inc.

Upsher Smith Laboratories, Inc. has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report