FDA DrugsClass II
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0...
Published: June 24, 2026Recall ID: D-0588-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Elmwood Park |
| State | NJ |
| Openfda › Upc › 1 | 0368462394847 |
| Openfda › Upc › 2 | 0368462394298 |
| Openfda › Upc › 3 | 0368462556849 |
| Openfda › Rxcui › 1 | 310463 |
| Openfda › Rxcui › 2 | 312033 |
| Openfda › Rxcui › 3 | 392662 |
| Openfda › Rxcui › 4 | 748797 |
| Openfda › Rxcui › 5 | 749852 |
| Openfda › Rxcui › 6 | 749858 |
| Openfda › Rxcui › 7 | 1242786 |
| Openfda › Rxcui › 8 | 1242787 |
| Openfda › Spl id | 9d4967e6-42df-4468-99a6-9b57499497d9 |
| Openfda › Brand name | ALYACEN 1/35 |
| Openfda › Spl set id | 5c02b4d3-1e2f-439a-ae45-02304ee190d1 |
| Openfda › Package ndc › 1 | 68462-556-84 |
| Openfda › Package ndc › 2 | 68462-556-29 |
| Openfda › Package ndc › 3 | 68462-394-84 |
| Openfda › Package ndc › 4 | 68462-394-29 |
| Openfda › Product ndc › 1 | 68462-394 |
| Openfda › Product ndc › 2 | 68462-556 |
| Openfda › Generic name | NORETHINDRONE AND ETHINYL ESTRADIOL |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Manufacturer name | Glenmark Pharmaceuticals Inc., USA |
| Openfda › Application number | ANDA091634 |
| Openfda › Is original packager | true |
| Event id | 99101 |
| Address 1 | 619 River Dr |
| Code info | Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027 |
| Postal code | 07407-1317 |
| Report date | 20260624 |
| Product type | Drugs |
| Reason for recall | Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260527 |
| Initial firm notification | Letter |
| Center classification date | 20260612 |
Overview
- Recalling FirmGlenmark Pharmaceuticals Inc., USA
- StatusOngoing
- Risk LevelClass II
- DistributionUSA Nationwide.