Recalls / Class II
Class IID-0021-2026
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 name
- Viorele
- Generic name
- Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol
- NDC
- 68462-318
- FDA application
- ANDA091346
- Affected lot / code info
- Batch number 20230733, Exp Date: October 2025
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 26,928 packs
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-09-03
- FDA classified
- 2025-10-15
- Posted by FDA
- 2025-10-22
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0021-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.