FDA Drug · D-0021-2026

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.

Class II · Ongoing

Failed Impurities/Degradation Specifications

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Affected lots / codes — check yours against thisBatch number 20230733, Exp Date: October 2025
Recalling firm
Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
Classification
Class II (temporary or reversible harm possible)
Status
Ongoing
Quantity
26,928 packs
Distribution
US Nationwide.
Recall initiated
September 3, 2025
Classified
October 15, 2025
Initiation
Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0021-2026%22
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Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →