Drug Recall: 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: Glen
Glenmark Pharmaceuticals Inc., USA · May 27, 2026
Reason for Recall
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
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
Distribution
USA Nationwide.
States Affected
NATIONWIDE
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0588-2026
Status: ongoing
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