Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg recall
Glenmark Pharmaceuticals Inc., USA recalled Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg on June 24, 2026 because of failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities. It was sold nationwide.
Why it was recalled
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
What's 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
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
USA Nationwide. - Status
- Ongoing
- Recall number
- D-0588-2026
- Source
- U.S. Food and Drug Administration
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