Epinephrine injection vials recalled for lack of assurance of sterility
Hospira Epinephrine Injection USP, 1 mg/10 mL, lots LY3681, LY4360 and LY4416, is recalled nationwide for lack of assurance of sterility. 49,620 vials are affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; loss of sterility assurance in an injectable medicine is a potential harm and no injuries are reported.
Plain-English summary
Epinephrine Injection, USP, 1 mg/10 mL (0.1 mg/mL), distributed by Hospira, Inc. of Lake Forest, Illinois, NDC 0409-4933-05 with case NDC 0409-4933-10, is being recalled. The prescription-only product is affected in lots LY3681, LY4360 and LY4416, all with an expiry of 02/28/2026. The recall covers 49,620 vials distributed nationwide.
The recall was issued for lack of assurance of sterility. The FDA classified the action as Class II.
Hospitals and pharmacies holding these lots should quarantine them, stop using them, and follow Hospira's instructions for return or replacement.
The recalled product
- 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.
- Manufacturer
- PFIZER INC
- Category
- Drug — Injectable
- Affected units
- 49,620
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 (4)
- Lot #: LY3681
- LY4360
- LY4416
- Exp. 02/28/2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by PFIZER INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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