FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

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

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 23, 2026 at 11:04 PM UTC.

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