Warning
Glenmark Pharmaceuticals Inc. Recalls Alyacen 7/7/7
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0588-2026Drug / Pharmaceutical
Glenmark Pharmaceuticals Inc. Recalls Alyacen 7/7/7
Glenmark Pharmaceuticals Inc., USA · Class II — Moderate Risk
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
USA Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a pharmaceutical product from Glenmark Pharmaceuticals Inc., USA, initiated on May 27, 2026. Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities. The product was distributed in USA Nationwide. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.