FDA recall D-0588-2026

Glenmark Pharmaceuticals Inc., USA · Class II · drug

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.

Distribution

USA Nationwide.

Key facts

Status: Ongoing
Initiation date: 2026-05-27
Report date: 2026-06-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Elmwood Park, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0588-2026