Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Kalbitor (ecallantide) Recalled by Shire Due to Presence of Particulate Matter: Glass

Date: March 17, 2017
Company: Shire
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Shire directly.

Affected Products

Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01

Quantity: 3, 536 cartons (3 vials per carton)

Why Was This Recalled?

Presence of Particulate Matter: Glass

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Shire

Shire has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report