Pfizer Inc. recalls Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials,
Pfizer recalls Fentanyl vials with loose metal seals that may compromise sterility. Affected vials have specific lot numbers and expiration dates. Stop using immediately if you have these vials.
Stop using this now
Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
Contact the company & request your remedy
What happened, in plain English
Pfizer is recalling Fentanyl vials that have loose metal seals, which could lead to contamination. This is serious because the medication is used for pain relief and contamination could cause infection or illness. Read more at govinfonow.com/recall/37386-pfizer-fentanyl-vials-recall-loose-metal-seal-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37386-pfizer-fentanyl-vials-recall-loose-metal-seal-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0835-2020
Cite this page
“Pfizer Fentanyl Vials Recall: Loose Metal Seal Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37386-pfizer-fentanyl-vials-recall-loose-metal-seal-risk. Based on FDA recall #D-0835-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0835-2020%22&limit=1).
Why it’s dangerous
The vials have loose metal seals that can allow contaminants to enter the medication. This could lead to infection or illness if the vials are used without proper sterility.
Who’s affected
People with prescriptions for Fentanyl injections who own vials with lot numbers 08133DK or 08134DK (tray) and 08-133-DK or 08-134-DK (vial) are affected. Those using the vials for pain relief are at highest risk.
How to tell if you have this one
Check the vial lot number on the packaging. Affected vials have lot numbers 08133DK or 08134DK (tray) and 08-133-DK or 08-134-DK (vial). The vials expire by February 1, 2021.
- Brand
Pfizer- Category
Drug
What to do — step by step
Stop Using Immediately
Discard any vials with lot numbers 08133DK or 08134DK (tray) and 08-133-DK or 08-134-DK (vial).
Questions people ask
Why is this vial dangerous?
The vials have loose metal seals that may allow contaminants to enter, risking infection or illness.
What should I do if I have these vials?
Discard the vials immediately and contact your healthcare provider for alternative pain management.
How can I check if my vial is affected?
Look for lot numbers 08133DK or 08134DK (tray) and 08-133-DK or 08-134-DK (vial) on the packaging.
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-0835-2020 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-0835-2020 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-0835-2020 (February 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0835-2020 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.