The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0578-2021·Announced 2021-06-02

Cardinal Health Recalls Epinephrine Auto-Injectors Due to Temperature Excursions

Cardinal Health is recalling 1,776 boxes of Epinephrine auto-injectors due to intermittent exposure to temperature excursions during storage.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cardinal Health Inc. is recalling 1,776 boxes of Epinephrine Injection USP, 0.15 mg (Auto-Injectors) for Allergic Emergencies (Anaphylaxis). The product, manufactured for Teva Pharmaceuticals USA, Inc., is identified by NDC 0093-5985-27 and lot code 025C20AA. The recall is being conducted due to CGMP deviations involving intermittent exposure to temperature excursions during storage.

The affected product was distributed in Florida, Georgia, and South Carolina. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The recall is limited to the specific lot and distribution areas mentioned.

The recalled product

Product
EPINEPHRINE (EPINEPHRINE)
Brand
EPINEPHRINE
Manufacturer
Cardinal Health Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
1,776

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 (1)

  • 025C20AA

UPCs (2)

  • 0300935985275
  • 0300935986272

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health Inc. 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 198 products in this recall →

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