United StatesAlyacen 7/7/7 (norethindrone and ethinyl estradiol tablets USP; 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg) in three blister cards each containing 28 tablets (28‑day regimen), Rx only, NDC 68462‑556‑29, lots 20240411 (exp. 6/30/2026) and 20250252 (exp. 3/31/2027) is being recalled. The recall was initiated because the product failed impurities/degradation specifications due to out‑of‑specification total impurities.
What's being recalled
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
Recalling firm: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ, United States.
How to identify it
Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
The hazard
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
USA Nationwide.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)