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OFFICIAL-SOURCE RECALL · UNITED STATES

American Regent, Inc Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose Recall: Presence of

Use the identifiers printed on your item to determine whether this recall may affect the product you own.

CountryUnited StatesPublishedSeptember 3, 2026Last updatedSeptember 3, 2026Official source last checkedOctober 7, 2026 at 5:00 PM UTC

CHECK THE ITEM YOU OWN

Is your product affected?

Brand
American Regent, Inc.
Product
Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial
Manufacturer
American Regent, Inc.
NDC
0517-3030-01, October2026, July2027, ContactInformation
Lot number
25128L1C0, December 16, 2025, June 15, 2026
Expiration date
August 2026, April 17, 2026, July 31, 2026
Package size
30 mL
Retailer
Walmart

The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.

Why this product was recalled

Presence of particulate matter and lack of sterility assurance

Hazard

Presence of particulate matter and lack of sterility assurance

What consumers should do

Consumers and healthcare professionals with questions regarding this recall can contact American Regent Inc. using the below information. Patients that use this product which is being recalled should stop using them and contact their doctor or health care provider.

Official recall notice

American Regent, Inc. Issues Voluntary Nationwide Recall of Three Lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) Due to the Presence of Particulate Matter and Lack of Assurance of Sterility

Agency: U.S. Food & Drug Administration

Official publication date: September 3, 2026

Read the official FDA recall notice →

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