Alyacen 7/7/7 Kit
FDA Recall NDC 68462-556
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Alyacen 7/7/7 (NDC 68462-556). A significant event, classified as Class II, was initiated on May 27, 2026 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
May 27, 2026
Jun 24, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99101
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide.
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
Batch or Lot Expiration Information
Lot# : 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
Affected Packages Involved in this Recall
68462-556-84Product
68462-556-29Product
68462-394-84Product
68462-394-29Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
