Alyacen 7/7/7 recall (Glenmark Pharmaceuticals Inc., USA)

DrugClass IIOngoing

Summary: Glenmark Pharmaceuticals Inc., USA is recalling 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 Pharmaceut. Reason: Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

What is being 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

Why

Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

USA Nationwide.

How to tell if yours is affected

Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

More recalls from Glenmark Pharmaceuticals Inc., USA · all drug recalls · recalls from May 2026

Official FDA record