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

Is NDC 60846-0301-15 recalled?

Nizatidine · 480 mL in 1 BOTTLE (60846-301-15)

Yes — this exact package was recalled

1 FDA recall names the code 60846-0301-15 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
Nizatidine
Strength
NIZATIDINE 15 mg/mL
Form
Solution · Oral
Labeler
Amneal Pharmaceuticals LLC
Type
Human Prescription Drug
Product code
60846-0301

Recalls naming this package

Class II ยท Moderate risk

Nizatidine Oral Solution

CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Terminated Nitrosamine impurity Amneal Pharmaceuticals of New York, LLC NDC 60846-301-15 D-1253-2020

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.