Pfizer Inc. recalls Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by
Pfizer recalls specific fentanyl vials due to potential sterility issues and metal seal defects. Affected vials have NDC 0409-9094-12 and specific expiration dates. Stop using immediately if you have these vials.
Stop using this now
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Contact the company & request your remedy
What happened, in plain English
Pfizer is recalling fentanyl injection vials that may have sterility issues or metal seal defects. This could lead to infections or other health risks if used improperly. Read more at govinfonow.com/recall/36928-pfizer-fentanyl-vials-recall-sterility-risk-in-injected-medication.
Source Summary by GovInfoNow · govinfonow.com/recall/36928-pfizer-fentanyl-vials-recall-sterility-risk-in-injected-medication · Updated October 5, 2026 · FDA enforcement record: FDA #D-1446-2020
Cite this page
“Pfizer Fentanyl Vials Recall: Sterility Risk in Injected Medication.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/36928-pfizer-fentanyl-vials-recall-sterility-risk-in-injected-medication. Based on FDA recall #D-1446-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1446-2020%22&limit=1).
Why it’s dangerous
The vials may not be sterile, which could cause infections. Loose metal seals might break during use, leading to contamination or injury.
Who’s affected
Prescription users of fentanyl injections who received vials with NDC 0409-9094-12 and specific expiration dates. Patients using these vials for pain management are most at risk.
How to tell if you have this one
Check for NDC code 0409-9094-12 on the vial label. Look for tray lots 13405DK or 17096DK with vial lots 13-405 DK or 17-096-DK expiring by July 2021 or November 2021.
- Brand
Pfizer- Category
Drug
What to do — step by step
Stop Using Vials Immediately
Discontinue use of all recalled fentanyl vials to prevent potential infections or injuries.
Questions people ask
Why is this fentanyl vial being recalled?
Pfizer recalls these vials due to potential sterility issues and metal seal defects that could cause infections or injuries.
How can I tell if I have a recalled vial?
Check for NDC code 0409-9094-12 and specific tray/vial lots with expiration dates of July 2021 or November 2021.
What should I do if I have a recalled vial?
Stop using the vial immediately and contact your healthcare provider for guidance.
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-1446-2020 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-1446-2020 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.
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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-1446-2020 (July 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1446-2020 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.