HIGH

Hospira Recalls Epinephrine Injection Due to Sterility Concerns

Hospira, Inc. recalled 49,620 vials of Epinephrine Injection on August 4, 2025. The recall follows concerns about the lack of assurance of sterility. Consumers should stop using the product immediately.

Quick Facts at a Glance

Recall Date
August 4, 2025
Hazard Level
HIGH
Brands
Epinephrine, Hospira
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Lack of Assurance of Sterility.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact PFIZER INC or your healthcare provider for guidance. Notification method: Letter

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Product Details

The recalled product is Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL). It was distributed by Hospira, Inc. and is identified by NDC 0409-4933-05.

The Hazard

The recall stems from a lack of assurance of sterility. This poses a high risk of infection and serious health complications for users.

Reported Incidents

No specific incidents or injuries have been reported at this time. The risk remains high due to the potential for contamination.

What to Do

Stop using the product immediately. Contact Pfizer Inc. or your healthcare provider for guidance on returning the product.

Contact Information

For more information, visit the FDA recall page or contact Pfizer Inc. directly for assistance and guidance.

Key Facts

  • 49,620 vials recalled
  • Distributed nationwide in the U.S.
  • Risk of infection due to sterility issues
  • Consumers should stop use immediately

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot #: LY3681
LY4360
LY4416
Exp. 02/28/2026
UPC Codes
0409-4933
0409-4933-11
0409-4933-01
+2 more
Affected States
ALL
Report Date
August 27, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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