American Regent Expands Epinephrine Injection Recall Over Cracked, Leaking Vials
The FDA announced an expanded recall of Epinephrine Injection, USP 30 mg per 30 mL due to cracking and leaking vials that could cause blockage and clotting in blood vessels.
3 reports on this incident · first at Sep 4, 2026, 9:13 a.m. ET
Earlier reports
Sep 4, 2026, 9:16 a.m. ET
FDA Reports Injuries Linked to American Regent Epinephrine Recall
The U.S. Food and Drug Administration (FDA) has received reports of injuries or illnesses connected to the recall of Epinephrine Injection, USP 30 mg per 30 mL vials manufactured by American Regent, according to Medical Daily. The agency did not specify the nature or number of these events.
The recall, initiated due to vials that were cracking and leaking, poses a hazard of blockage and clotting in blood vessels. The affected lots are identified by codes 25128L1C0, 25280L1C0, and 26108L1C0, with NDC 0517-3030-01. The recall is nationwide.
The FDA advises consumers to stop using the product and either return it to the place of purchase or discard it. No further details on the reported adverse events have been provided.
Sep 4, 2026, 9:13 a.m. ETFirst report
American Regent Recalls Epinephrine Injection Vials Over Cracking and Leaking
American Regent is recalling Epinephrine Injection, USP 30 mg per 30 mL nationwide, according to the FDA as reported by Medical Daily. The recall was initiated because the vials were cracking and leaking, which could cause blockage and clotting in blood vessels.
The affected product can be identified by the following codes: 25128L1C0, 25280L1C0, 26108L1C0, and NDC 0517-3030-01. No adverse events connected to the recall have been reported.
Consumers are advised to stop using the product and either return it to the place of purchase or discard it.
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- Version 14 Sept 2026, 13:22current
First published.
- Version 14 Sept 2026, 13:13current
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- Version 14 Sept 2026, 13:16current
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