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

Is NDC 58468-0160-01 recalled?

Lumizyme · 1 VIAL, SINGLE-USE in 1 CARTON (58468-0160-1) / 10.5 mL in 1 VIAL, SINGLE-USE

Yes — this exact package was recalled

1 FDA recall names the code 58468-0160-01 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
Alglucosidase Alfa
Strength
ALGLUCOSIDASE ALFA 5 mg/mL
Form
Injection, Powder, for Solution · Intravenous
Labeler
Genzyme Corporation
Type
Human Prescription Drug
Product code
58468-0160

Recalls naming this package

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