FDAFDA recall D-0588-2026 · Jun 24, 2026
Glenmark Pharmaceuticals Inc., USA: Alyacen 7/7/7 recall
Recall found
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 for recall
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
- Distribution
- USA Nationwide.
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-27
Source: openFDA enforcement record D-0588-2026 · search recall number D-0588-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.