Glenmark Pharmaceuticals Inc., USA recalls Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Bliste…
- Recall date
- September 3, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0021-2026
- FDA classification
- Class II
- Brand / firm
- Glenmark Pharmaceuticals Inc., USA
- Sold / distributed
- US Nationwide.
Why it was recalled
Failed Impurities/Degradation Specifications
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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