Recall archive / FDA company announcement

American Regent, Inc.: Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial — FDA announcement Sep 3, 2026

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Sep 3, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial
Reason: Presence of particulate matter and lack of sterility assurance
Classification: Not supplied
Recalling firm: American Regent, Inc.
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: be0db24ddef68063

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) packaged in a multi dose vials, administered intravenously, intramuscularly, or subcutaneously and is to be used by or under the direction of a physician. Epinephrine Injection, USP is indicated for the emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine Injection, USP is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Epinephrine Injection, USP is a clear, colorless, sterile solution available in a 30 mL multiple-dose vial containing 1 mg/mL. The affected Lot Numbers 25128L1C0, 25280L1C0, and 26108L1C0 were distributed nationwide, in the United States.; Specific NDC numbers, lot numbers, expiration dates and distribution dates can be found in the table below.; Product \| NDC \| Lot \| Expiry \| Distribution Date Range; \| \| \| \| Beginning \| End; Epinephrine Injection, USP \| 0517-3030-01 \| 25128L1C0 \| August 2026 \| September 04, 2025 \| December 18, 2025; 25280L1C0 \| October 2026 \| December 16, 2025 \| April 17, 2026; 26108L1C0 \| July 2027 \| June 15, 2026 \| July 31, 2026; Contact Center \| Contact Information \| Area of Support; American Regent, Inc. Customer Service \| Phone: 800-645-1706 (8:00AM-6:00PM EST, Monday – Thursday, 8:00AM- 4:00PM EST, Friday) \| For detailed return/replacement/credit information; American Regent, Inc. Pharmacovigilance \| Phone: 800-734-9236 Email: [email protected] \| To report adverse events; American Regent, Inc. Product Quality Complaints \| Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: [email protected] \| For product quality complaints; American Regent, Inc. Medical Information \| Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: [email protected] \| For medical questions

Label field

Details supplied by the agency

Lot, code or applicability

Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) packaged in a multi dose vials, administered intravenously, intramuscularly, or subcutaneously and is to be used by or under the direction of a physician. Epinephrine Injection, USP is indicated for the emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine Injection, USP is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Epinephrine Injection, USP is a clear, colorless, sterile solution available in a 30 mL multiple-dose vial containing 1 mg/mL. The affected Lot Numbers 25128L1C0, 25280L1C0, and 26108L1C0 were distributed nationwide, in the United States.; Specific NDC numbers, lot numbers, expiration dates and distribution dates can be found in the table below.; Product | NDC | Lot | Expiry | Distribution Date Range; | | | | Beginning | End; Epinephrine Injection, USP | 0517-3030-01 | 25128L1C0 | August 2026 | September 04, 2025 | December 18, 2025; 25280L1C0 | October 2026 | December 16, 2025 | April 17, 2026; 26108L1C0 | July 2027 | June 15, 2026 | July 31, 2026; Contact Center | Contact Information | Area of Support; American Regent, Inc. Customer Service | Phone: 800-645-1706 (8:00AM-6:00PM EST, Monday – Thursday, 8:00AM- 4:00PM EST, Friday) | For detailed return/replacement/credit information; American Regent, Inc. Pharmacovigilance | Phone: 800-734-9236 Email: [email protected] | To report adverse events; American Regent, Inc. Product Quality Complaints | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: [email protected] | For product quality complaints; American Regent, Inc. Medical Information | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: [email protected] | For medical questions

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
Product	NDC	Lot	Expiry	Distribution Date Range
				Beginning	End
Epinephrine Injection, USP	0517-3030-01	25128L1C0	August 2026	September 04, 2025	December 18, 2025
		25280L1C0	October 2026	December 16, 2025	April 17, 2026
		26108L1C0	July 2027	June 15, 2026	July 31, 2026

FDA company announcement, table 2
Contact Center	Contact Information	Area of Support
American Regent, Inc. Customer Service	Phone: 800-645-1706 (8:00AM-6:00PM EST, Monday – Thursday, 8:00AM- 4:00PM EST, Friday)	For detailed return/replacement/credit information
American Regent, Inc. Pharmacovigilance	Phone: 800-734-9236 Email: [email protected]	To report adverse events
American Regent, Inc. Product Quality Complaints	Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: [email protected]	For product quality complaints
American Regent, Inc. Medical Information	Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: [email protected]	For medical questions

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: Sep 3, 2026
Company announcement date: Sep 3, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.