Agency classClass IOur severity:Critical FDA (Drugs)·D-0865-2026·Announced 2026-09-16

American Regent Recalls Epinephrine Vials Due to Particulate Matter

American Regent, Inc. is recalling 31,935 vials of Epinephrine Injection due to the presence of particulate matter and broken vials.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

American Regent, Inc. is recalling 31,935 vials of Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL). The recall affects multiple-dose vials intended for intravenous infusion, intramuscular, and subcutaneous use. The product was distributed nationwide within the U.S.A.

The recall was initiated because of the presence of particulate matter and a lack of assurance of sterility. Particulate matter identified in the product includes nylon, cellulosic, acrylic, polyethylene, and glass. Additionally, broken and leaking vials were identified.

The affected lots are 25128L1C0 (Exp. August 31, 2026), 25280L1C0 (Exp. October 31, 2026), and 26108L1C0 (Exp. July 31, 2027). Healthcare providers and patients should stop using the recalled product and contact their pharmacist or the manufacturer for further instructions.

The recalled product

Product: EPINEPHRINE (EPINEPHRINE)
Brand: EPINEPHRINE
Manufacturer: American Regent, Inc.
Category: Drug — Injection
Hazard: particulate-matter
sterility

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

Lots: 25128L1C0
Exp. August 31
2026
25280L1C0
Exp. October 31
26108L1C0
Exp. July 31
2027

Distribution

Distributed nationwide across the United States.

Same brand · EPINEPHRINE

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Same manufacturer · American Regent, Inc.

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