Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 0185-0128-01 recalled?

Bumetanide · 100 TABLET in 1 BOTTLE (0185-0128-01)

Yes — this exact package was recalled

1 FDA recall names the code 0185-0128-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
Bumetanide
Strength
BUMETANIDE .5 mg/1
Form
Tablet · Oral
Labeler
Sandoz Inc
Type
Human Prescription Drug
Product code
0185-0128

Recalls naming this package

Class III ยท Low risk

Bumetanide Tablets USP 0.5 mg. Rx Only

Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.

Terminated Temperature excursion Sandoz Inc D-341-2014

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler