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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Baxter Healthcare Corporation: Sevoflurane Inhalation Anesthetic Recalled for Failed Stability Specifications

Agency Publication Date: June 13, 2019
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Summary

Baxter Healthcare Corporation is recalling approximately 5,940 bottles of Sevoflurane, USP Inhalation Anesthetic (250 mL). This prescription medication is being recalled because the product failed stability specifications during testing, which means the drug may not maintain its required quality or potency throughout its shelf life. Consumers should immediately check their supplies for the specific lot number affected by this recall.

Risk

The failure to meet stability specifications can lead to the drug losing its effectiveness or developing impurities over time, which may result in unpredictable anesthesia depth or other adverse clinical outcomes during surgery.

What You Should Do

  1. Check your inventory for Sevoflurane, USP Inhalation Anesthetic in 250 mL bottles with NDC 10019-651-64.
  2. Specifically look for Lot #: S110F822 with an expiration date of 5/31/2021.
  3. Immediately stop using any product from the affected lot and set it aside to ensure it is not administered to patients.
  4. Contact your healthcare provider or pharmacist for guidance regarding the use of this medication.
  5. Return any unused product from the affected lot to your pharmacy or place of purchase for a refund and contact Baxter Healthcare Corporation for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund
How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Sevoflurane, USP Inhalation Anesthetic (250 mL)
Model:
NDC 10019-651-64
Recall #: D-1435-2019
Lot Numbers:
S110F822 (Exp. 5/31/2021)
Date Ranges: Expiration Date 5/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83055
Status: Resolved
Manufacturer: Baxter Healthcare Corporation
Sold By: hospitals; surgical centers; pharmacies
Manufactured In: United States
Units Affected: 5940 bottles
Distributed To: Nationwide
Agency Last Updated: June 28, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.