FDA Drug · 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: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29

Class II · Ongoing

Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

Affected lots / codes — check yours against thisLot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027

Recalling firm: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: —
Distribution: USA Nationwide.
Recall initiated: May 27, 2026
Classified: June 12, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0588-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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