Viorele Kit
FDA Recall NDC 68462-318
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 Viorele (NDC 68462-318). A significant event, classified as Class II, was initiated on Sep 03, 2025 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
September 2025 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Ongoing
Failed Impurities/Degradation Specifications
Sep 03, 2025
Oct 22, 2025
26,928 packs
Recall Profile & Regulatory Data
Event ID
97547
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA., Mahwah, NJ, 07430, NDC 68462-318-29.
Batch or Lot Expiration Information
Batch# Batch number 20230733, Exp Date: October 2025
Affected Packages Involved in this Recall
68462-318-84Product
68462-318-29Product
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.
