Skip to content
Unrated Drug recall · FDA · Published August 22, 2022

Pfizer PROPOFOL Injectable Emulsion Recall: Particulate Matter Hazard

Pfizer recalls PROPOFOL Injectable Emulsion (100 mL glass vials) due to particulate matter. This may cause serious complications during medical use. Affected units have specific NDC numbers and lot numbers.

🇺🇸 FDA recall #D-1540-2022DrugPfizer ›
Take action

Contact the company

Recalling firmPfizer Inc.235 East 42nd Street · New York, NY 10017-5703
✎ GovInfoNow plain-language explainer

Pfizer is recalling PROPOFOL Injectable Emulsion vials that contain particulate matter. This could lead to serious complications if used in medical procedures. The recall affects specific vial lots with the NDC 0409-4699-54. Read more at govinfonow.com/recall/34359-pfizer-propofol-injectable-emulsion-recall-particulate-matter-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/34359-pfizer-propofol-injectable-emulsion-recall-particulate-matter-hazard · Updated August 18, 2026 · FDA enforcement record: FDA #D-1540-2022

Cite this page

“Pfizer PROPOFOL Injectable Emulsion Recall: Particulate Matter Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34359-pfizer-propofol-injectable-emulsion-recall-particulate-matter-hazard. Based on FDA recall #D-1540-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1540-2022%22&limit=1).

Pfizer Inc. recalled PROPOFOL Injectable Emulsion due to the presence of particulate matter, according to the Food and Drug Administration on Aug. 22, 2022. The agency announced the Class I recall of 5,390 vials distributed nationwide.

How to tell if you have it

  • Brand: Pfizer
  • Product: PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL)
  • Packaging: 100 mL glass fliptop vial in a tray of 10 vials
  • NDC: 0409-4699-54 (vial), 0409-4699-24 (carton)
  • Lot code: EA7470
  • Expiration date: 6/1/2023
  • Distributor: Hospira, Inc., Lake Forest, IL
  • Quantity: 5,390 vials

The hazard

The recall addresses the presence of particulate matter in the product. The FDA classified this as a Class I recall, indicating a reasonable probability that the use of the product will cause serious adverse health consequences or death.

Context

GovInfoNow's records show Pfizer Inc. has 71 other recalls on record since Nov. 26, 2012. Recent Pfizer recalls include a Sodium Bicarbonate Injection recall for lack of sterility assurance on Aug. 4, 2025, and a Bicillin L-A injectable recall due to particulate risk on July 10, 2025. Other recent recalls of similar products include a Pfizer Dopamine HCl Inj Recall for lack of sterility risk on Sept. 4, 2026, a B. Braun Medical Lactated Ringer's Injection Recall for particulate matter hazard on Aug. 12, 2026, and an American Regent Papaverine HCl Injection Recall for particulate matter hazard on July 24, 2026.

How to tell if you have this one

Check for vials with NDC 0409-4699-54 and lot number EA7470. The product is packaged in 100 mL glass fliptop vials within a tray of 10 vials (NDC Carton: 0409-4699-24).

  • Brand
    Pfizer
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Vial Lot Number

    Look for lot number EA7470 on the vial packaging. If this lot number is present, the vial is part of the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.9 years after the firm started it.

1. Firm started the recall: Aug 22, 202212. FDA classified it Class I: Sep 19, 202223. Published in FDA’s Enforcement Report: Sep 21, 202234. FDA terminated the recall: Jun 30, 2025420222025
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest drug recalls

Keep exploring

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-1540-2022 (August 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1540-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA