Rybelsus Tablet
FDA Recall NDC 0169-4307
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Rybelsus (NDC 0169-4307). A significant event, classified as Class II, was initiated on Mar 15, 2021 by Novo Nordisk Pharmaceutical Industries, Lp. The reported reason for this action was: "CGMP Deviations: Intermittent exposure to temperature excursion during storage."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
1189 cartons
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs. Each pack contains 10 tablets. Rx only NDC 0169-4307-13 Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark
Batch or Lot Expiration Information
Lot# K082347
Affected Packages Involved in this Recall
0169-1715-30Product
0169-1715-90Product
0169-1704-30Product
0169-1709-30Product
0169-4303-01Product
0169-4303-13Product
0169-4303-90Product
0169-4303-93Product
0169-4303-30Product
0169-4303-99Product
0169-4307-01Product
0169-4307-13Product
0169-4307-30Product
0169-4314-01Product
0169-4314-13Product
0169-4314-30Product
0169-4815-30Product
0169-4815-90Product
0169-4804-30Product
0169-4809-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
