WhichRecall
Class IIReported 2025-10-22

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.

Recalled by Glenmark Pharmaceuticals Inc., USA

Reason for Recall

Failed Impurities/Degradation Specifications

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Recall Number
D-0021-2026
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-09-03
Reported
2025-10-22
Distribution
US Nationwide.
Code Info
Batch number 20230733, Exp Date: October 2025
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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