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

Is NDC 0338-5197-41 recalled?

Famotidine · 12 BAG in 1 CARTON (0338-5197-41) / 50 mL in 1 BAG

Yes — this exact package was recalled

2 FDA recalls name the code 0338-5197-41 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.

1 of these recalls is still ongoing.

Active ingredient
Famotidine
Strength
FAMOTIDINE 20 mg/50mL
Form
Injection, Solution · Intravenous
Labeler
Baxter Healthcare Corporation
Type
Human Prescription Drug
Product code
0338-5197

Recalls naming this package

Class II · Moderate risk

Famotidine Injection 20 mg

Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.

Terminated Particulate / foreign matter Baxter Healthcare Corp. NDC 0338-5197-41 D-0293-2015

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