FDA-Drug2026-06-24Class IICHEMICAL

Glenmark Alyacen 7/7/7 birth control recalled for failed purity specifications

OTHERNationwide distribution

Glenmark Alyacen 7/7/7 birth control recalled for impurity levels

Glenmark Pharmaceuticals is recalling specific lots of Alyacen 7/7/7 (a birth control pill) because testing found higher-than-allowed impurity levels in the tablets. The affected lots were distributed nationwide. No injuries have been reported.

  • Check if your Alyacen 7/7/7 matches lot #20240411 (expires 6/30/2026) or lot #20250252 (expires 3/31/2027).
  • If you have an affected lot, contact your pharmacy or prescriber before stopping the medication.
  • Do not stop taking your birth control without talking to your doctor first, as this could affect contraceptive protection.
Hazard

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

Sold states
USA Nationwide.
Manufactured in
619 River Dr, Elmwood Park, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0588-2026

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