The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0524-2021·Announced 2021-06-02

Cardinal Health Recalls Steglatro Tablets Due to Temperature Excursions

Cardinal Health is recalling 215 bottles of Steglatro (ertugliflozin) 15 mg tablets due to intermittent 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, which typically indicates a reasonable probability of temporary or medically reversible health consequences. The hazard involves storage conditions (temperature excursions) rather than a confirmed contamination or defect causing immediate harm, fitting the Moderate severity criteria for potential quality issues without reported injuries.

Plain-English summary

Cardinal Health Inc. is recalling 215 bottles of Steglatro (ertugliflozin) 15 mg tablets, 30-count bottles. The product was distributed in Florida, Georgia, and South Carolina. The recall is due to CGMP deviations involving intermittent exposure to temperature excursions during storage.

The affected product is identified by lot code T013566. Steglatro is a prescription oral medication manufactured for Merck Sharp & Dohme Corp. The recall is classified as Class II by the FDA.

Consumers with this product should contact their healthcare provider or pharmacist for guidance on whether to discontinue use or obtain a replacement.

The recalled product

Product
STEGLATRO (ERTUGLIFLOZIN)
Brand
STEGLATRO
Manufacturer
Cardinal Health Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
215

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)

  • T013566

UPCs (2)

  • 0300065363035
  • 0300065364032

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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