United StatesViorele oral contraceptive tablets (Desogestrel 0.15 mg/Ethinyl Estradiol 0.02 mg and Ethinyl Estradiol 0.01 mg), packaged as 3 blisters each containing 28 tablets, NDC 68462-318-29, Batch 20230733, Exp October 2025, manufactured by Glenmark Pharmaceuticals Limited and distributed by Glenmark Pharmaceuticals Inc. is being recalled. The recall covers 26,928 packs sold nationwide in the US by Glenmark Pharmaceuticals Inc., Mahwah, NJ. The product was recalled due to failed impurities/degradation specifications.
What's being 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.
Recalling firm: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States.
How to identify it
Batch number 20230733, Exp Date: October 2025
The hazard
Failed Impurities/Degradation Specifications
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)