FDAClass IIAugust 27, 2025

Vial Label: Epinephrine Injection recall: Sterility Concern

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.

Why was Vial Label: Epinephrine Injection recalled?

Lack of Assurance of Sterility.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: LY3681, LY4360, LY4416, Exp. 02/28/2026

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.
Recalling firm
PFIZER INC
Quantity
49,620 vials
Distribution
U.S. Nationwide
Recall date
August 27, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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