FDAHealthAugust 4, 2025
PFIZER INC — 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.
⚠️ Lack of Assurance of Sterility.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 4, 2025
U.S. Nationwide
What's affected?
- 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.
- Brand
- PFIZER INC
- Lot code
- LY3681
Additional details
Lot #: LY3681, LY4360, LY4416, Exp. 02/28/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 49,620 vials.
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