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American Regent recalls epinephrine vials over particulate matter, sterility risk

American Regent recalls epinephrine vials over particulate matter, sterility risk

Rule Changes Holt, MI local

Three lots of a critical emergency drug pulled nationwide after customer complaints of cracked vials and contamination

3 days ago: FDA publishes recall notice

Overview

Updated 1 hour ago

American Regent, Inc. issued a voluntary nationwide recall of three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi-dose vials after customer complaints of leaking and cracked vials raised sterility concerns. The company's investigation found particulate matter — nylon, cellulosic, acrylic, polyethylene, and glass — in the product, which can cause blood vessel blockage, pulmonary embolism, organ damage, or death if administered intravenously.

The recalled lots were distributed across the United States between September 2025 and July 2026. Epinephrine is a critical emergency drug used to treat anaphylaxis and septic shock, so the recall affects hospitals, clinics, and first responders who rely on these vials for life-threatening situations. No adverse events linked to the recalled lots had been reported as of the September 3 announcement, and the company is arranging returns and replacements.

Why it matters

If a contaminated epinephrine vial is used intravenously, particles can block blood flow to vital organs and cause death — and this drug is often the only option during anaphylaxis or septic shock.

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Key Indicators

3
Lots recalled
Lots 25128L1C0, 25280L1C0, and 26108L1C0, distributed nationwide September 2025 through July 2026.
30 mg/30 mL
Product strength
Multi-dose vials of 1 mg/mL epinephrine, NDC 0517-3030-01.
0
Adverse events reported
American Regent had not received any reports of adverse events related to this recall as of September 3, 2026.
11 months
Distribution window
Affected lots were distributed from September 4, 2025 to July 31, 2026.

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People Involved

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American Regent Quality Department
Manufacturer's quality assurance team responsible for the recall investigation
Conducting recall, arranging returns and replacements

Organizations Involved

American Regent, Inc.
American Regent, Inc.
Pharmaceutical Manufacturer
Issued voluntary recall; conducting return/replacement program

Ohio-based manufacturer of sterile injectable pharmaceuticals, including epinephrine.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal Regulatory Agency
Acknowledged and published the recall notice

Federal agency that regulates drug safety and publishes recall notices.

Timeline

September 2025 September 2026

5 events Latest: 3 days ago
Tap a bar to jump to that date

  1. FDA publishes recall notice

    Latest Regulatory

    FDA alerts consumers, retailers, and healthcare facilities to stop using the product.

  2. American Regent issues voluntary recall

    Recall

    Company recalls three lots after complaints of cracked vials and particulate contamination.

  3. Third affected lot begins distribution

    Distribution

    Lot 26108L1C0 begins shipping; distribution runs through July 31, 2026.

  4. Second affected lot begins distribution

    Distribution

    Lot 25280L1C0 begins shipping; distribution runs through April 17, 2026.

  5. First affected lot begins distribution

    Distribution

    Lot 25128L1C0 begins shipping nationwide.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

September-October 2012

New England Compounding Center fungal meningitis outbreak (2012)

A compounding pharmacy in Massachusetts shipped contaminated steroid injections that were administered to patients across 20 states. The product had not been properly sterilized, and 753 people developed fungal meningitis, with 64 deaths.

Then

The FDA shut down the facility, and criminal charges followed against the pharmacy's operators.

Now

Congress passed the Drug Quality and Security Act in 2013, creating a new regulatory category for compounding pharmacies and giving the FDA inspection authority.

Why this matters now

This recall involves a sterility failure in an injectable drug, the same mechanism that made the 2012 outbreak fatal. It shows how sterility lapses in injectables can move from manufacturing defect to patient harm.

2014-2024

FDA particulate matter recalls in injectables (2010s-2020s)

Multiple sterile injectable recalls occurred over particulate contamination — glass, rubber, and metal fragments in vials — including several chemotherapy drugs and blood pressure medications. Each prompted FDA guidance on visual inspection and quality control.

Then

Manufacturers issued recalls and tightened visual inspection protocols, but the FDA repeatedly cited glass vials and stopper materials as recurring contamination sources.

Now

The FDA's 2024 draft guidance on particulate matter in injectables pushed manufacturers toward formal risk assessments and improved inspection technology.

Why this matters now

This recall fits a decade-long pattern of particulate contamination in sterile injectables, showing the FDA's ongoing struggle to enforce quality in vial and stopper manufacturing.

March 2017

Mylan EpiPen recall for defective auto-injectors (2017)

Mylan recalled EpiPen auto-injectors distributed between 2015 and 2016 after two complaints that the devices failed to activate properly, meaning patients in anaphylaxis could receive no dose at all.

Then

Mylan replaced recalled units and the FDA later added the product back to shortage lists.

Now

The recall underscored how fragile the epinephrine supply chain is — a single manufacturer's quality failure can leave patients without access to a life-saving drug.

Why this matters now

Epinephrine is a critical emergency drug where product reliability is a matter of life and death. This case shows the market's dependency on a small number of manufacturers.

Sources

(3)
U.S. Food and Drug Administration WLNS 6 News KOCO