Glenmark recalls Viorele birth control tablets because they failed impurity and degradation tests
The tablets did not meet the required limits for impurities and breakdown products, meaning the medicine may not meet quality standards.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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.
- Hazard
- Failed Impurities/Degradation Specifications
- Units
- 26,928 packs
- Where sold
- US Nationwide.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 15, 2025
- Recall started
- September 3, 2025
- FDA enforcement report
- October 22, 2025
- Identifiers
- Codes: Batch number 20230733, Exp Date: October 2025
- FDA recall number: D-0021-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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.
- Reason for recall
- Failed Impurities/Degradation Specifications
- Classification
- Class II (Ongoing)
- Distribution
- US Nationwide.
- Quantity
- 26,928 packs
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