Recalls / Class II
Class IID-0590-2025
Product
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
- Affected lot / code info
- Lot #: LY3681, LY4360, LY4416, Exp. 02/28/2026
Why it was recalled
Lack of Assurance of Sterility.
Recalling firm
- Firm
- PFIZER INC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 68 Hudson Blvd E, N/A, New York, New York 10001-2188
Distribution
- Quantity
- 49,620 vials
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-08-04
- FDA classified
- 2025-08-18
- Posted by FDA
- 2025-08-27
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0590-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.