FDA Drug recall 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 containi…
- FDA Drug
- Class II
- ongoing
- Published 2026-06-24
On 2026-06-24 the FDA classified a Class II recall of 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 containi… by Glenmark Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0588-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-27 |
| Published | 2026-06-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Identifiers
| ndc | 68462-556-84 |
|---|---|
| ndc | 68462-556-29 |
| ndc | 68462-394-84 |
| ndc | 68462-394-29 |
| code_info | Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0588-2026%22
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