Thyrogen (Genzyme) – Glass Particle Contamination (2016)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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, Storage: store at 2-8 C, Manufactured by: Genzyme Corporation, Northborough, MA 01532 USA, Marketing Authorization holder: Sanofi-Aventis, NDC 58468-0030-2.
Brand
Genzyme Corporation
Lot Codes / Batch Numbers
Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017
Products Sold
Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017
Genzyme Corporation is recalling Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injecti due to Presence of Particulate Matter: Glass particles found in the product after reconstitution.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026