Pfizer Inc. recalls Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer
Pfizer recalls Elelyso (taliglucerase alfa) injections after reports of loose metal ferrules causing potential contamination. Affected vials have specific lot numbers and expiration dates.
Stop using this now
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.
Contact the company & request your remedy
What happened, in plain English
Pfizer has recalled Elelyso (taliglucerase alfa) injections because some vials have loose metal ferrules that could lead to contamination. This risk is serious enough that users should stop using the product immediately. Read more at govinfonow.com/recall/37355-pfizer-recalls-elelyso-injections-due-to-metal-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37355-pfizer-recalls-elelyso-injections-due-to-metal-contamination-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0995-2020
Cite this page
“Pfizer recalls Elelyso injections due to metal contamination risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37355-pfizer-recalls-elelyso-injections-due-to-metal-contamination-risk. Based on FDA recall #D-0995-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0995-2020%22&limit=1).
Why it’s dangerous
The vials have loose metal ferrules that can lift or dislodge during use, potentially causing metal contamination. This contamination could lead to serious health issues if injected.
Who’s affected
People prescribed Elelyso injections by a doctor. Those with the specific lot numbers and expiration dates listed in the recall are most at risk.
How to tell if you have this one
Check the vial for loose metal ferrules that lift or dislodge when flipping the orange plastic button. Look for lot numbers X14209, X46389, X78365, AT2927, AH4601, AH4602, AH4603, AL8590 with specific expiration dates.
- Brand
Pfizer- Category
Drug
What to do — step by step
Stop using it now
Immediately discard any Elelyso vials with loose metal ferrules that lift or dislodge during use.
Questions people ask
What is the specific hazard with Elelyso?
The vials have loose metal ferrules that can lift or dislodge when flipping the orange plastic button, potentially causing metal contamination.
Which lot numbers are affected?
Lot numbers X14209, X46389, X78365, AT2927, AH4601, AH4602, AH4603, AL8590 with specific expiration dates.
How can I check if my vial is affected?
Check if the vial has loose metal ferrules that lift or dislodge when flipping the orange plastic button.
Contact Pfizer
We’ve drafted a message you can send Pfizer to request your refund or repair — edit it as you like.
Subject: Recall D-0995-2020 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-0995-2020 from Pfizer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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-0995-2020 (February 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0995-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.