Why it was recalled
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Product 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
Lot numbers, UPCs & expiration codes
Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
Where it was sold
USA Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0588-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 27, 2026
- FDA report date
- Jun 24, 2026
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0588-2026, exactly as published.
Show all FDA fields
- City
- Elmwood Park
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99101
- Address
- 619 River Dr
- Code information
- Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
- Postal code
- 07407-1317
- Report date
- Jun 24, 2026
- Product type
- Drugs
- Recall number
- D-0588-2026
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Reason for recall
- Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- USA Nationwide.
- Recall initiation date
- May 27, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 12, 2026