Drug recall D-0588-2026
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 for recall
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Lots and codes
Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ
- Distribution
- USA Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 27, 2026
Related products
- Alyacen 1/35 – drug information
- NDC 68462-394 Alyacen 1/35 · · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-556 Alyacen 7/7/7 · · Glenmark Pharmaceuticals Inc., USA