ALYACEN 1/35
Recalling Firm / Manufacturer: Glenmark Pharmaceuticals Inc., USA
(Elmwood Park, NJ, United States)
FDA Recall Number: D-0588-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
ALYACEN 1/35
Generic Name
NORETHINDRONE AND ETHINYL ESTRADIOL
Active Substance(s)
Not provided by source
Administration Route
Not provided by source
National Drug Code (NDC)
68462-394
Total Quantity Recalled
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
June 24, 2026
Firm Initiation Date
May 27, 2026
FDA Classification Date
Jun 12, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
Distribution Information
Geographic scope of affected shipments
USA Nationwide.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0588-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508602UTCC