Shire Kalbitor (ecallantide) 10mg/mL vials recalled due to glass particles
Shire recalls Kalbitor (ecallantide) 10mg/mL vials for glass particles. This medication is prescription-only and sold in 3-vial cartons with specific lot and expiration details.
Use caution until it’s fixed
Presence of Particulate Matter: Glass
Contact the company
What happened, in plain English
Shire has recalled Kalbitor (ecallantide) 10mg/mL vials due to glass particles. This could cause serious injury if injected. The product is prescription-only and sold in 3-vial cartons with specific lot numbers. Read more at govinfonow.com/recall/41807-shire-kalbitor-ecallantide-10mg-ml-vials-recalled-due-to-glass.
Source Summary by GovInfoNow · govinfonow.com/recall/41807-shire-kalbitor-ecallantide-10mg-ml-vials-recalled-due-to-glass · Updated October 8, 2026 · FDA enforcement record: FDA #D-0625-2017
Cite this page
“Shire Kalbitor (ecallantide) 10mg/mL vials recalled due to glass particles.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41807-shire-kalbitor-ecallantide-10mg-ml-vials-recalled-due-to-glass. Based on FDA recall #D-0625-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0625-2017%22&limit=1).
Why it’s dangerous
Glass particles in the vials could cause injury if injected. This is a serious hazard because the medication is injected directly into the body.
Who’s affected
Prescription patients using Kalbitor (ecallantide) 10mg/mL vials from Shire. Those with the specific lot number A1500009 are most at risk.
How to tell if you have this one
Check for the lot number A1500009 on the carton. The product is a prescription-only medication sold in 3-vial cartons with an expiration date of January 31, 2019.
- Brand
Shire- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number A1500009 on the carton to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Kuwait” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.2 years 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.
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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-0625-2017 (March 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0625-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.