Genzyme Corporation
NDC labeler code: 58468
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Sevelamer carbonateRenvela · 3 products
- Agalsidase betaFabrazyme · 2 products
- FitusiranQfitlia · 2 products
- TeriflunomideAubagio · 2 products
- AlemtuzumabCampath, Lemtrada · 2 products
- Olipudase alfa-rpcpXenpozyme · 2 products
- VandetanibCaprelsa · 2 products
- Anti-thymocyte globulin (rabbit)Thymoglobulin · 1 product
- Avalglucosidase alfa-ngptNexviazyme · 1 product
- EliglustatCerdelga · 1 product
- RilzabrutinibWayrilz · 1 product
- ImigluceraseCerezyme · 1 product
- Thyrotropin alfaThyrogen · 1 product
- LaronidaseAldurazyme · 1 product
- Alglucosidase alfaLumizyme · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| August 29, 2025 | NDA219685 | Rilzabrutinib WAYRILZ | Genzyme Corp |
| March 28, 2025 | NDA219019 | Fitusiran QFITLIA | Genzyme Corp |
| August 31, 2022 | BLA761261 | Olipudase alfa-rpcp XENPOZYME | Genzyme Corp |
| August 6, 2021 | BLA761194 | Avalglucosidase alfa-ngpt NEXVIAZYME | Genzyme Corp |
| August 19, 2014 | NDA205494 | Eliglustat CERDELGA | Genzyme Corp |
| September 12, 2012 | NDA202992 | Teriflunomide AUBAGIO | Sanofi Aventis Us |
| April 6, 2011 | NDA022405 | Vandetanib CAPRELSA | Genzyme Corp |
| May 24, 2010 | BLA125291 | Alglucosidase alfa LUMIZYME | Genzyme |
| August 12, 2009 | NDA022318 | Sevelamer carbonate RENVELA | Genzyme |
| October 19, 2007 | NDA022127 | Sevelamer carbonate RENVELA | Sanofi |
| April 30, 2003 | BLA125058 | Laronidase ALDURAZYME | Biomarin |
| April 24, 2003 | BLA103979 | Agalsidase beta FABRAZYME | Genzyme |
| May 7, 2001 | BLA103948 | Alemtuzumab CAMPATH, LEMTRADA | Genzyme |
| November 30, 1998 | BLA020898 | Thyrotropin alfa THYROGEN | Genzyme |
| May 23, 1994 | BLA020367 | Imiglucerase CEREZYME | Genzyme |
| — | BLA103869 | Anti-thymocyte globulin (rabbit) | — |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2016
-
February 16, 2016 · Class II · Terminated · D-0730-2016 · Thyrotropin alfa
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials per Carton, Carton contains 2 vials of Thyrogen, Dilute with Sterile Water for Injection, St
2015
-
December 8, 2015 · Class III · Terminated · D-0799-2016 · Alglucosidase alfa
Labeling: Incorrect or Missing Lot and/or Exp Date
Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026