Notice names this product. Glenmark Pharmaceuticals’s Alyacen 7/7/7 is named in FDA Class II recall D-0588-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities. Identifying details: Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Company / brand: Glenmark Pharmaceuticals
Affected product: Alyacen 7/7/7
Official ID D-0588-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.