Drug FDA Class II Ongoing Contamination / non-sterility
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.
PFIZER INC Published Aug 27, 2025
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact PFIZER INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Lack of Assurance of Sterility.
Hazards
Lack of Assurance of Sterility · primary
Affected products (1)
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.
49,620 vials
Code info: Lot #: LY3681, LY4360, LY4416, Exp. 02/28/2026
Affected areas
Nationwide
Timeline
- InitiatedAug 4, 2025
- PublishedAug 27, 2025
- Recall number
- D-0590-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.