CLASS II Drug recall · Reported 19 Jun 2019 · FDA Enforcement Report
Sevoflurane, USP Inhalation Anesthetic recalled by Baxter Healthcare
Baxter Healthcare is recalling Sevoflurane, USP Inhalation Anesthetic, distributed nationwide in the US. The recall was initiated on 13 Jun 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1435-2019
- FDA event ID
- 83055
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Sevoflurane
- Manufacturer
- Baxter Healthcare Company
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jun 2019
- FDA classified
- 28 Jun 2019
- Reported
- 19 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 13 Jun 2019 | Recall initiated by company | |
| 19 Jun 2019 | Published in enforcement report | +6 days |
| 28 Jun 2019 | Classified by FDA | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Stability Specifications
Which lots are affected?
Lot #: S110F822 Exp. 5/31/2021
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Baxter Healthcare
All 573| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS I | 0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Drug | CLASS II | Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
Other Sevoflurane recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Ultane (sevoflurane), Inhalation Anesthetic recalled by AbbVieUltane | AbbVie | Packaging Defects | MS, OH |
| Drug | CLASS II | Sevoflurane, USP (Inhalation Anesthetic) recalledSevoflurane | Piramal Critical Care | Other | Nationwide |