Class II
Ongoing
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.
This recall is currently active, issued October 22, 2025. It was issued by Glenmark Pharmaceuticals Inc., Usa.
- Recall Initiated
- September 3, 2025
- Posted
- October 22, 2025
- Recall Number
- D-0021-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 26,928 packs
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
US Nationwide.
Lot / Code Info
Batch number 20230733, Exp Date: October 2025
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