Genzyme Corporation

FDA recalling firm · 4 enforcement events · 6 product records · 2012–2017 · MA

Genzyme Corporation has 4 FDA enforcement events on this register (6 product records) between 2012 and 2017: 3 drug and 1 device; the busiest year was 2012 with 1.

0% of its events are Class I; the most common class is Class II (2). 0 events are listed as ongoing; the recalling firm's address is in MA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
12 Oct 2017	Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01.	Drug	Class III	1	Terminated
16 Feb 2016	Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Four vials per Carton, Carton contains 2 vials of Thyrogen and 2 vials of diluent, Storage: store at 2-8 C, Genzyme Corporation, Cambridge, MA 02142, NDC 58468-1849-04.	Drug	Class II	2	Terminated
8 Dec 2015	Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1	Drug	Class III	1	Terminated
13 Jun 2012	seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the…	Device	Class II	2	Terminated

By type and class

Drug3

Device1

Class II2

Class III2

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Genzyme Corporation by year initiated.

Questions and answers

How many FDA recalls has Genzyme Corporation had?

4 enforcement events (6 product records) on this register, 2012–2017: 3 drug, 1 device.

Are any Genzyme Corporation recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Genzyme Corporation recalls?

2 Class II, 2 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.