FDAFDA · Food and drugs·Recall number 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.
Published October 22, 2025 · Recall initiated: September 3, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- VIORELE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- US Nationwide.
- Lot
- Batch number 20230733, Exp Date: October 2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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