Agency classClass IIOur severity:High FDA (Drugs)·D-1022-2022·Announced 2022-06-15

Adrenalin epinephrine vials recalled nationwide due to temperature-abuse deviations

McKesson Medical-Surgical is recalling Adrenalin (epinephrine) 30 mL vials nationwide due to cGMP deviations involving temperature abuse during manufacturing. Temperature excursions may compromise drug potency.

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: FDA Class II recall of a life-critical emergency medication. While no illnesses or deaths have been reported, temperature abuse of epinephrine could reduce drug potency, creating a risk of harm to patients relying on this medication in emergencies.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling Adrenalin (epinephrine injection, USP) 30 mg/30 mL (1 mg/mL) multiple-dose vials. The recall affects 58 cartons distributed nationwide throughout the United States.

The recall was initiated due to cGMP deviations, specifically temperature abuse during manufacturing. Temperature excursions may affect the potency and safety of the drug.

Customers have been notified with distribution dates and shipment dates to help identify potentially affected product. McKesson Medical-Surgical was unable to identify specific lot numbers but has provided customers with timeframes to determine if their product may have been affected.

The recalled product

Product: ADRENALIN (EPINEPHRINE)
Brand: ADRENALIN
Manufacturer: Mckesson Medical-Surgical Inc. Corporate Office
Category: Drug — Injectable - Emergency Use
Hazard: temperature-abuse
manufacturing-deviation
Affected units: 58

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 · ADRENALIN

High
Adrenalin Epinephrine Injection Recalled Due to Incorrect Expiration Date Label
FDA (Drugs) · 2024-02-28

Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office

See all →

Moderate
Strep A test kits recalled after shipment to unlicensed purchasing customers
FDA (Devices) · 2025-08-27
Moderate
Prolia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
Moderate
Evenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
Moderate
Benlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
Moderate
Abbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
FDA (Devices) · 2025-06-04

Same hazard · temperature abuse