Lower risk Drug recall · FDA · Published August 4, 2025

Pfizer Epinephrine Vial Recall: Risk of Contaminated Injection

Pfizer recalls epinephrine injection vials with lot numbers LY3681, LY4360, LY4416 due to lack of sterility assurance. These vials may cause infection if used.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0590-2025Drug Pfizer ›

Lower-risk recall

Lack of Assurance of Sterility.

Take action

Contact the company

Recalling firmPFIZER INC68 Hudson Blvd E · New York, NY 10001-2188

✎ GovInfoNow plain-language explainer

Pfizer is recalling epinephrine injection vials that could be contaminated, posing a risk of infection if used. This recall affects specific lot numbers distributed by Hospira. Read more at govinfonow.com/recall/31890-pfizer-epinephrine-vial-recall-risk-of-contaminated-injection.

Source Summary by GovInfoNow · govinfonow.com/recall/31890-pfizer-epinephrine-vial-recall-risk-of-contaminated-injection · Updated August 17, 2026 · FDA enforcement record: FDA #D-0590-2025

Cite this page

“Pfizer Epinephrine Vial Recall: Risk of Contaminated Injection.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31890-pfizer-epinephrine-vial-recall-risk-of-contaminated-injection. Based on FDA recall #D-0590-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0590-2025%22&limit=1).

Pfizer Inc. recalled Epinephrine Injection, USP vials distributed by Hospira, Inc., due to a lack of assurance of sterility, the FDA said on Aug. 4, 2025. Owners should contact Pfizer for a remedy.

How to tell if you have it

Brand: Pfizer
Product: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only
Distributed by: Hospira, Inc., Lake Forest, IL
NDC (Vial): 0409-4933-05
NDC (Case): 0409-4933-10
Lot codes: LY3681, LY4360, LY4416
Expiration date: 02/28/2026
Quantity: 49,620 vials
Distribution: U.S. Nationwide

The hazard

The recall addresses a lack of assurance of sterility in the affected epinephrine injection vials.

Context

GovInfoNow's records show Pfizer Inc. has 71 other recalls on record since Nov. 26, 2012. Other recent recalls include a July 10, 2025 Bicillin L-A suspension recall for particulate risk and a May 28, 2025 Dobutamine injection recall for discoloration risk. Similar recent recalls of epinephrine products include an April 1, 2026 sterility risk recall and an Aug. 11, 2026 American Regent particulate matter recall.

How to tell if you have this one

Check the vial label for the product name 'Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL)' and lot numbers LY3681, LY4360, or LY4416. These vials were distributed by Hospira in the US.

Brand
Pfizer
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
U.S. Nationwide

Recall number	Product, codes & lots	Quantity	NDC
D-0590-2025	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.; Lot #: LY3681, LY4360, LY4416, Exp. 02/28/2026	49,620 vials	—
D-0591-2025	Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.; Lot #: LH2671, Exp. 11/30/2026	15,750 vials	0409-4916-24, 0409-4916-14, 0409-6637-24, 0409-6637-14, 00409-6637-14

Based on the official FDA remedy

What to do — step by step

Check Vial Label
Look for lot numbers LY3681, LY4360, or LY4416 on the vial label.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 23 days after the firm started it.

Aug 4, 2025Firm started the recall
Aug 18, 2025FDA classified it Class II
Aug 27, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31890-pfizer-epinephrine-vial-recall-risk-of-contaminated-injection">Pfizer Epinephrine Vial Recall: Risk of Contaminated Injection (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0590-2025 (August 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0590-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.