US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 15, 2021 (5 years ago)

Steglatro (ertugliflozin) tablets 15 mg 30 Tablets Rx only NDC 0006-5364-03 Manuf. for…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

What was recalled

Steglatro (ertugliflozin) tablets 15 mg 30 Tablets Rx only NDC 0006-5364-03 Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA

Recalling firm
Cardinal Health Inc.
NDC code
0006-5364-03
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0524-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.