Hospira Recalls Amidate Etomidate Injection Due to Degradation Impurities
Hospira Inc. is recalling 24,100 syringes of Amidate (Etomidate Injection) because stability testing confirmed out-of-specification degradation products.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as unlikely to cause adverse health consequences. The issue involves out-of-specification degradation products without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Hospira Inc. is recalling 24,100 syringes of Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL). The product is distributed in 20 mL glass Abboject syringes with male luer lock adapters and is available by prescription only. The specific lot affected is 34-531-DK, with an expiration date of 10/01/2015.
The recall was initiated because out-of-specification (OOS) results for a degradation product of etomidate were confirmed during stability testing. This indicates that the impurities or degradation levels in the medication exceeded the established specifications.
The affected product was distributed nationwide. Healthcare providers and patients should discontinue use of the recalled lot and contact Hospira Inc. for further instructions or replacement.
The recalled product
- Product
- Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 24,100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 34-531-DK
- Exp 10/01/2015
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Hospira Inc.
See all →- CriticalHospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
- ModerateHospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
- LowHospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
- SevereHospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
- HighHospira Symbiq Infusion Pump Recall for White Screen Safety Shutdown
FDA (Devices) · 2016-11-16
Same hazard · impurities
See all →- LowDabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- ModerateGlycopyrrolate Oral Solution Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-29
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- ModerateMethohexital Sodium 100 mg/10 mL Compounded Drug Recalled Nationwide
FDA (Drugs) · 2026-07-15
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08