Pfizer Inc. recalls Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed
Pfizer recalls sterile water vials for injection due to insect particulate matter found in one vial. This affects specific lot numbers and requires immediate action to prevent potential contamination.
Lower-risk recall
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Contact the company & request your remedy
What happened, in plain English
Pfizer is recalling sterile water vials for injection because an insect was found in one vial. This could lead to contamination if the water is used for drug preparation, so affected users should stop using the vials and contact Pfizer for a replacement. Read more at govinfonow.com/recall/36161-pfizer-sterile-water-for-injection-vials-recall-insect-particulate-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/36161-pfizer-sterile-water-for-injection-vials-recall-insect-particulate-hazard · Updated October 4, 2026 · FDA enforcement record: FDA #D-0384-2021
Cite this page
“Pfizer Sterile Water for Injection Vials Recall: Insect Particulate Hazard.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36161-pfizer-sterile-water-for-injection-vials-recall-insect-particulate-hazard. Based on FDA recall #D-0384-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0384-2021%22&limit=1).
Why it’s dangerous
The presence of insect particulate matter in one vial could contaminate the sterile water used for drug preparation. This poses a risk of infection or adverse reactions if the contaminated water is administered to patients.
Who’s affected
Healthcare professionals and pharmacies that received the specific lot numbers (DN9185) of Pfizer's sterile water vials. Patients using these vials for drug preparation are at risk if the vials are contaminated.
How to tell if you have this one
Check for the lot number DN9185 on the vial packaging. The product is labeled as 'Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only.'
- Brand
Pfizer- Category
Drug
What to do — step by step
Check Vial Lot Number
Look for the lot number DN9185 on the vial packaging to confirm if it is affected.
Contact Pfizer
Reach out to Pfizer directly for a replacement or guidance on next steps.
Questions people ask
Is this recall affecting patients directly?
No, this recall is for healthcare professionals and pharmacies that received the specific lot numbers. Patients do not use these vials directly.
How can I tell if I have the recalled vials?
Check for the lot number DN9185 on the vial packaging. The product is labeled as 'Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only.'
What should I do if I have the recalled vials?
Contact Pfizer directly for a replacement or guidance on next steps.
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-0384-2021 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-0384-2021 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-0384-2021 (May 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0384-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.