Alyacen 7/7/7 — Class II drug recall D-0588-2026
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2026-06-24, distributed nationwide. Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification resul
| Recall number | D-0588-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ, United States |
| Recall initiated | 2026-05-27 |
| Classified | 2026-06-12 |
| Reported by FDA | 2026-06-24 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 68462-0394, 68462-0394-29, 68462-0394-84, 68462-0556, 68462-0556-29, 68462-0556-84 |
| Lot numbers | 20240411, 20250252 |
| Expiration dates | 2026-06-30, 2027-03-31 |
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
Reason for recall
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0588-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.