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Class II · ModerateActive recall

Alyacen 1/35

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
Where it was soldUSA Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byGlenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 foreign manufacturer
Brand nameALYACEN 1/35
Generic nameNORETHINDRONE AND ETHINYL ESTRADIOL
Distributed by / forGlenmark Pharmaceuticals Inc., Mahwah, NJ 07430
NDC68462-556-29
Show the full FDA record
Full product labelAlyacen 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
Recalling firmGlenmark Pharmaceuticals Inc., USA
DistributionUSA Nationwide.
Recall initiated2026-05-27
Report date2026-06-24
Recall completed—
Recall numberD-0588-2026
ClassificationClass II
FDA statusOngoing
Origin on fileElmwood Park NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.