Pfizer Inc. recalls Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs,
Pfizer recalls Elelyso (taligl: 200 units/vial) injections due to loose metal ferrule crimps that may cause contamination. Affected lots include S91616. Patients should contact their doctor for guidance.
Use caution until it’s fixed
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 is recalling Elelyso injections because loose metal ferrules on the vials can become dislodged during use, potentially causing contamination. This poses a risk of infection for patients receiving the medication. Read more at govinfonow.com/recall/39560-pfizer-elelyso-injection-recall-loose-metal-ferrule-crimps-risk-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/39560-pfizer-elelyso-injection-recall-loose-metal-ferrule-crimps-risk-contamination · Updated October 6, 2026 · FDA enforcement record: FDA #D-0005-2019
Cite this page
“Pfizer Elelyso injection recall: Loose metal ferrule crimps risk contamination.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39560-pfizer-elelyso-injection-recall-loose-metal-ferrule-crimps-risk-contamination. Based on FDA recall #D-0005-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0005-2019%22&limit=1).
Why it’s dangerous
The vials have loose metal ferrule crimps that can lift or dislodge when flipping off the orange plastic button. This may lead to contamination of the injection solution, increasing infection risk during use.
Who’s affected
Patients prescribed Elelyso injections by a doctor. Those with the specific lot number S91616 are most at risk.
How to tell if you have this one
Check the lot number on the vial label, which should be S91616 for this recall. The product is a 200-unit/vial injection for medical use only.
- Brand
Pfizer- Category
Drug
What to do — step by step
Contact Your Doctor
Your healthcare provider will advise on next steps for the recall.
Questions people ask
Is this product safe to use?
The recall indicates a risk of contamination from loose metal ferrules, so it is not safe to use without medical guidance.
How can I check if I have the recalled product?
Look for the lot number S91616 on the vial label; this product is a 200-unit/vial injection for medical use only.
What should I do if I have the recalled product?
Contact your doctor for instructions on how to handle the product safely.
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-0005-2019 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-0005-2019 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.
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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-0005-2019 (September 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0005-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.