Agency classClass IIOur severity:High FDA (Drugs)·D-1013-2022·Announced 2022-06-15

FDA Recalls Epinephrine Auto-Injectors Due to Temperature Abuse

McKesson is recalling 55 packs of epinephrine auto-injectors nationwide due to temperature abuse during manufacturing. This represents a deviation from manufacturing standards.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm product—epinephrine auto-injectors are critical emergency medications—where no injury or illness has been reported. The hazard is theoretical rather than confirmed harm.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling Epinephrine Injection, USP, Single-Dose Auto-Injectors (0.3 mg) due to cGMP deviations involving temperature abuse during manufacturing. The affected product was manufactured by Mylan Pharma and distributed nationwide in 55 packs.

Temperature exposure during manufacturing represents a deviation from Current Good Manufacturing Practice standards. Epinephrine is a critical emergency medication used to treat severe allergic reactions, and temperature deviations during manufacturing could affect product quality and efficacy.

McKesson Medical-Surgical Inc. was unable to identify specific lot numbers received by individual customers. The company has provided distribution dates in individual recall notifications to help customers identify potentially affected products. Customers who received affected products should contact McKesson Medical-Surgical Inc. for further instructions.

The recalled product

Product: EPINEPHRINE (EPINEPHRINE)
Brand: EPINEPHRINE
Manufacturer: Mckesson Medical-Surgical Inc. Corporate Office
Category: Drug — Prescription Auto-Injector
Hazard: temperature-abuse
Affected units: 55

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 130 products in this recall →

Same brand · EPINEPHRINE

Critical
American Regent Recalls Epinephrine Vials Due to Particulate Matter
FDA (Drugs) · 2026-09-16
Moderate
Fresenius Kabi epinephrine injection vials failed impurities and degradation specifications
FDA (Drugs) · 2026-06-17
High
IMS epinephrine injection vials recalled over lack of sterility assurance
FDA (Drugs) · 2026-04-22
High
Epinephrine Auto-Injector Recalled for Temperature Abuse During Manufacturing and Distribution
FDA (Drugs) · 2022-06-15
Moderate
Cardinal Health Recalls Epinephrine Auto-Injectors Due to Temperature Excursions
FDA (Drugs) · 2021-06-02

Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office

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Benlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
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Same hazard · temperature abuse