--- title: "American Regent, Inc.: Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) mult... — FDA announcement Sep 3, 2026 | Is It on Recall" description: "Presence of particulate matter and lack of sterility assurance" url: https://isitonrecall.com/recall/fdapress-be0db24ddef68063-american-regent-inc-epinephrine-injection-usp-30-mg-30-ml-1-mg-ml-multi-dose-vial/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## 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](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-regent-inc-issues-voluntary-nationwide-recall-three-lots-epinephrine-injection-usp-30-mg-30) ## 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: pv@americanregent.com \| To report adverse events; American Regent, Inc. Product Quality Complaints \| Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: pqc@americanregent.com \| For product quality complaints; American Regent, Inc. Medical Information \| Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: ma@americanregent.com \| 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 | Distribution Date Range | | --- | --- | --- | --- | --- | --- | | | | | | Beginning | End | | Epinephrine Injection, USP | 0517-3030-01 | 25128L1C0 | August 2026 | September 04, 2025 | December 18, 2025 | | Epinephrine Injection, USP | 0517-3030-01 | 25280L1C0 | October 2026 | December 16, 2025 | April 17, 2026 | | Epinephrine Injection, USP | 0517-3030-01 | 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: pv@americanregent.com | To report adverse events | | American Regent, Inc. Product Quality Complaints | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: pqc@americanregent.com | For product quality complaints | | American Regent, Inc. Medical Information | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: ma@americanregent.com | For medical questions | Announcement retrieved Oct 1, 2026. [Official announcement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-regent-inc-issues-voluntary-nationwide-recall-three-lots-epinephrine-injection-usp-30-mg-30). ## 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. ## What to do next 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. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. [Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-regent-inc-issues-voluntary-nationwide-recall-three-lots-epinephrine-injection-usp-30-mg-30) ## Related records [Other food records](https://isitonrecall.com/category/other-food/) [American Regent, Inc. records](https://isitonrecall.com/brand/american-regent-inc/)