On March 15, 2021, a Class II recall was initiated for Rybelsus (semaglutide) Tablets 7 mg, listed under recall identifier D-0536-2021. The recall record title references an Ozempic recall entry, though the affected product described is Rybelsus. The recalling firm named in the record is Cardinal Health Inc. The stated reason for the recall was CGMP deviations, specifically intermittent exposure to temperature excursions during storage. The affected product is identified as NDC 0169-4307-13, packaged as 30 tablets in three blister packs of 10 tablets each, manufactured by Novo Nordisk A/S in Bagsvaerd, Denmark. This action is classified as Class II by the FDA. According to the record, the recall status is terminated. The record does not provide additional detail on lot numbers, quantities affected, or downstream distribution. No information on adverse events tied to this recall was included in the data reviewed. This brief reflects only the details contained in the FDA recall entry. For general background on semaglutide, an approved compound, readers can refer to the semaglutide overview for further context.
Semaglutide (Rybelsus) Class II Recall Initiated March 2021
Drafted by an automated content engine from FDA, PubChem, ClinicalTrials.gov, NIH DSLD, and Open Beauty Facts data.
See the full semaglutide overview
Source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts