Norethindrone/Ethinyl Estradiol Recall: Alyacen 7/7/7
Announced 2026-06-24 · FDA
The FDA recall affects Alyacen 7/7/7 (Norethindrone and Ethinyl Estradiol) and Viorele (Desogestrel and Ethinyl Estradiol) tablets due to failed impurities/degradation specifications. About 26,928 packs distributed nationwide in the US are involved, batch 20230733, expiration October 2025.
| Brand | Glenmark Pharmaceuticals Inc., USA |
|---|---|
| Product | Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA., Mahwah, NJ, 07430, NDC 68462-318-29. |
| Reason | Failed Impurities/Degradation Specifications |
| Severity | moderate |
| Units affected | 26,928 packs |
| Distribution | US Nationwide. |
| Agency | FDA |
| Recall / campaign no. | Batch number 20230733, Exp Date: October 2025 |
WHAT YOU SHOULD DO
- Do not use any recalled packs that match batch 20230733 and expiration October 2025.
- Consult your healthcare provider for advice and possible alternatives or replacement.
- Contact your pharmacy or the manufacturer for return, refund, or disposal instructions.
Other Glenmark Pharmaceuticals Inc., USA recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.