Genzyme Lumizyme Recall: FDA Class III

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Exp Date

Product description

Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1

Lot numbers, UPCs & expiration codes

Lot # C5370C02; Exp. 02/18

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0799-2016
Classification: Class III
Status: Terminated
Recall initiated: Dec 8, 2015
FDA report date: Apr 6, 2016
Quantity: 24 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Genzyme Corporation

Original FDA data

Every field from FDA enforcement report D-0799-2016, exactly as published.

Show all FDA fields

City: Cambridge
State: MA
Status: Terminated
Country: United States
Event ID: 72929
Address: 500 Kendall Street
Address (line 2): 675 West Kendall/55 Cambridge Parkway
Code information: Lot # C5370C02; Exp. 02/18
Postal code: 02142-1108
Report date: Apr 6, 2016
Product type: Drugs
Recall number: D-0799-2016
Classification: Class III
Recalling firm: Genzyme Corporation
Product quantity: 24 vials
Termination date: Aug 1, 2016
Reason for recall: Labeling: Incorrect or Missing Lot and/or Exp Date
Voluntary / mandated: Voluntary: Firm initiated
Product description: Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1
Distribution pattern: TN
Recall initiation date: Dec 8, 2015
Initial firm notification: E-Mail
Center classification date: Mar 31, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0799-2016, published Apr 6, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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Genzyme Lumizyme Recall

Summary