🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: May 27, 2026 Glenmark Pharmaceuticals Inc., USA Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Glenmark Pharmaceuticals Inc., USA
Reason for Recall:
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0588-2026

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