Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Elelyso (taliglucerase alfa) for injection Recalled by Pfizer Inc. Due to Lack of Assurance of Sterility--Reports of loose metal...
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 Pfizer Inc. directly.
Affected Products
Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01
Quantity: 24,714 vials
Why Was This Recalled?
Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Pfizer Inc.
Pfizer Inc. has 114 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report