FDAHealthMay 27, 2026
Glenmark Pharmaceuticals Inc., USA — 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 re
⚠️ Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 27, 2026
USA Nationwide.
What's affected?
- 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
- Brand
- ALYACEN 1/35
- UPC
- 0368462394847
- Lot code
- 20240411
Additional details
Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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