Recall: D-0588-2026

Class II - Potentially Harmful

Class IIClassification

2026-05-27Initiated

OngoingStatus

Glenmark Pharmaceuticals Inc.,Firm

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.

Distribution

USA Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.