American Regent Recalls Three Epinephrine Lots Over Cracked Vials

Container integrity failures and multi-material particulate contamination have forced American Regent, Inc. to recall three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi-dose vials nationwide, a dual-failure profile that will draw immediate scrutiny from QA directors managing injectable lines and vial inspection programs.

Customer complaints triggered the action: leaking and cracked vials generated a lack of sterility assurance, and the firm's subsequent investigation identified particulate matter composed of Nylon, Cellulosic, Acrylic, Polyethylene, and Glass. The co-occurrence of physical container failure and multi-source particulate contamination points to compounding gaps across incoming material qualification, in-process vial inspection, and complaint-triggered CAPA closure, each a discrete audit exposure under 21 CFR Part 211.

Affected lot numbers 25128L1C0, 25280L1C0, and 26108L1C0 carry expiry dates ranging from August 2026 through July 2027 and were distributed nationally between September 2025 and July 2026. The product is indicated for emergency treatment of anaphylaxis and hypotension associated with septic shock, a critical-use context that elevates the clinical consequence of any sterility breach. American Regent reports no adverse events to date.

The FDA risk statement is unambiguous: intravenous administration of particulate-laden solution can cause vascular occlusion, pulmonary embolism, permanent organ damage, or death. Cracked vials independently compromise container-closure integrity, introducing contamination risk that sterility testing alone cannot retrospectively resolve, a point directly relevant to sites relying on end-product testing as a primary sterility control rather than a confirmatory one, contrary to ICH Q10 quality system expectations.

American Regent is notifying distributors and customers by letter and arranging returns and replacements. Healthcare facilities holding affected stock are directed to cease use and return product to the place of purchase. Pharmacovigilance and return inquiries can be directed to American Regent Customer Service at 800-645-1706.

For QA and regulatory leads, the particulate identification data, spanning five distinct material classes, will likely inform the scope of FDA's follow-up inspection and the breadth of the CAPA the agency expects to see documented before the affected line returns to full commercial operation.

Source: U.S. Food and Drug Administration, Recalls, Market Withdrawals and Safety Alerts, September 3, 2026.