FDAHealthSeptember 3, 2025
Glenmark Pharmaceuticals Inc., USA — 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 d
⚠️ Failed Impurities/Degradation Specifications
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 3, 2025
US Nationwide.
What's affected?
- Product
- 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.
- Brand
- VIORELE
- Lot code
- Batch number 20230733, Exp Date: October 2025
Additional details
Batch number 20230733, Exp Date: October 2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 26,928 packs.
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