Glenmark Pharmaceuticals Inc., USA recalls Alyacen 7/7/7
- Recalling company
- Glenmark Pharmaceuticals Inc., USA
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- May 27, 2026
- Reported
- Jun 24, 2026
- Distribution
- USA Nationwide.
- Status
- Ongoing
- Lot / codes
- Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
- Company location
- Elmwood Park, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0588-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0588-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.