MedicineWatch US
Class II Recall

Glenmark Pharmaceuticals Inc., USA

Product
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29
Reason
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Classification
Class II
Status
Ongoing
Lot
Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Glenmark Pharmaceuticals Inc., USA — Class II Recall | MedicineWatch US