FDA Drugs recall ·
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP… recall
- Recall number
- D-0588-2026
- Date
- (initiated May 27, 2026)
- Company / brand
- Glenmark Pharmaceuticals Inc., USA
619 River Dr, Elmwood Park, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
Distribution
USA Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0588-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.