D-0588-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- June 24, 2026
- Initiation Date
- May 27, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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 for Recall
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Distribution Pattern
USA Nationwide.
Code Information
Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027