Thyrogen Recall: Glass Particulates in Injection Vials
Genzyme recalls Thyrogen vials due to glass particles found after reconstitution. Check lot numbers E4029Y03, E4029Y04, E4029Y06, and E4029Y07 immediately.
Stop using this now
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Contact the company
What happened, in plain English
Genzyme Corporation is recalling Thyrogen (thyrotropin alfa for injection) because glass particles were found in the product after it was reconstituted. This recall affects specific lots distributed nationwide and internationally. The presence of particulate matter in an injectable drug poses a risk to patients receiving the medication. Read more at govinfonow.com/recall/43143-thyrogen-recall-glass-particulates-in-injection-vials.
Source Summary by GovInfoNow · govinfonow.com/recall/43143-thyrogen-recall-glass-particulates-in-injection-vials · Updated October 11, 2026 · FDA enforcement record: FDA #D-0730-2016
Cite this page
“Thyrogen Recall: Glass Particulates in Injection Vials.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43143-thyrogen-recall-glass-particulates-in-injection-vials. Based on FDA recall #D-0730-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0730-2016%22&limit=1).
Why it’s dangerous
Injecting glass particles can cause serious physical harm, including blockage of blood vessels, inflammation, or embolisms. The hazard occurs specifically after the product is reconstituted with sterile water for injection.
Who’s affected
Patients who have been prescribed or received Thyrogen injection vials from the affected lots are at risk. Healthcare providers administering this medication to these patients must also be aware of the recall.
How to tell if you have this one
Check if you have Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL, manufactured by Genzyme Corporation. Look for NDC 58468-0030-2 and one of the following lot numbers: E4029Y03, E4029Y04, E4029Y06, or E4029Y07 with an expiration date of 12/2017.
- Brand
Thyrogen- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0729-2016 | 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.; Lot #: E4029Y02 (carton), E4029 (vial) Exp 09/2016 | 27,022 vials | — |
| D-0730-2016 | 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.; Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017 | 4669 Cartons | 58468-0030-1, 58468-0030-2, 58468-1849-4 |
What to do — step by step
Stop Using Affected Lots
Do not use any Thyrogen vials from the recalled lot numbers due to the risk of glass particulates.
Contact Healthcare Provider
Inform your doctor or pharmacist if you have received or used these specific lots so they can assess any potential health impacts.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Where was this product sold?
The product was distributed nationwide in the U.S., as well as in Puerto Rico, Malaysia, Taiwan, Brazil, and Israel.
What is the NDC number for the recalled product?
The National Drug Code (NDC) is 58468-0030-2.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0730-2016 (February 16, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0730-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.