Genentech Activase 100mg Vials Recall: Cracked Glass Risk
Genentech recalls 58 million IU Activase vials due to cracked glass in sterile water vials, posing contamination risks. Consumers should check for cracks and contact Genentech for details.
Recall notice
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Contact the company
What happened, in plain English
Genentech is recalling 58 million IU of Activase (alteplase) vials because the sterile water vials may have cracked glass. This could lead to contamination if the medication is used. Affected users should stop using the product and contact Genentech for guidance. Read more at govinfonow.com/recall/41265-genentech-activase-100mg-vials-recall-cracked-glass-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41265-genentech-activase-100mg-vials-recall-cracked-glass-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-1175-2017
Cite this page
“Genentech Activase 100mg Vials Recall: Cracked Glass Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41265-genentech-activase-100mg-vials-recall-cracked-glass-risk. Based on FDA recall #D-1175-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1175-2017%22&limit=1).
Why it’s dangerous
The sterile water vials that come with the Activase medication may have cracked or chipped glass. If the glass is damaged, it could contaminate the medication, leading to potential health risks when the product is used.
Who’s affected
People who have the Activase 100mg vials with the specific lot numbers and expiration dates listed in the recall notice are affected. Those using the product for clot treatment are at higher risk.
How to tell if you have this one
Check the vial for cracks or chips at the neck of the sterile water vial. The product includes lot numbers 3128243, 3141239 (expiring 9/30/2018) and 3166728 (expiring 2/28/2019).
- Brand
Genentech- Category
Drug
What to do — step by step
Check for Cracks
Inspect the neck of the sterile water vial for cracks or chips.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class I
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1175-2017 (September 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1175-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.