FDAClass II · Drug · Recalled June 24, 2026

Alyacen 7/7/7 recall — Glenmark Pharmaceuticals Inc., USA

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0588-2026
Brand: Glenmark Pharmaceuticals
Classification: Class II
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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

Affected products

Alyacen 7/7/7

Companies & origin

Recalling firm location: Elmwood Park, NJ, United States
Firm address: 619 River Dr, 07407-1317

Identifying details (verbatim from the notice)

Product codes / lots: Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
Distribution: USA Nationwide.
Firm notified the public via: Letter
FDA event ID: 99101
Recall initiated: May 27, 2026
FDA classified: June 12, 2026
FDA report date: June 24, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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