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 Blister
Recalled October 22, 2025 · FDA recall D-0021-2026 · Glenmark Pharmaceuticals Inc., USA
Hazard
Failed Impurities/Degradation Specifications · FDA Class II
Units
26,928 packs
Sold at
US Nationwide.
Description
Failed Impurities/Degradation Specifications
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.
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →