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FDARecalled Jun 24, 2026 · #D-0588-2026

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: G...

Hazard

Class II — temporary health risk

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Description

Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities. Classification: Class II Distribution: USA Nationwide.

Product details

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
Type
Drugs
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Model numbers
20240411
UPCs