Reported Jun 24, 2026 · Ongoing

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…

Glenmark Pharmaceuticals Inc., USA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Glenmark Pharmaceuticals Inc., USA · 619 River Dr · Elmwood Park, NJ · 07407-1317

Is this the product you have?

  • 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 byGlenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India
  • Manufactured forGlenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29
Lot codes and dates
  • Lot #: 20240411
  • Exp
    • 6/30/2026
    • 20250252
  • Exp3/31/2027

Where 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 4:19 PM UTC

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