Quick Facts at a Glance
- Recall Date
- May 27, 2026
- Hazard Level
- HIGH
- Brands
- ALYACEN 1/35, Glenmark Pharmaceuticals Inc., USA
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- ALYACEN 1/35, Glenmark Pharmaceuticals Inc., USA
- Model numbers
- Lot #: 20240411, Exp: 6/30/2026, 20250252, Exp: 3/31/2027
- UPC codes
- 68462-394, 68462-556, 68462-556-84, 68462-556-29, 68462-394-84, 68462-394-29
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 27, 2026
Reported by FDA DRUG
June 24, 2026
RecallRadar source check
June 30, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Glenmark Pharmaceuticals Inc., USA or your healthcare provider for guidance. Notification method: Letter
Get instant alerts for ALYACEN 1/35 recalls
Be the first to know. Free instant alerts to your inbox.
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. Generic: NORETHINDRONE AND ETHINYL ESTRADIOL; Brand: ALYACEN 1/35. Reason: Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.. Classification: Class II. Distribution: USA Nationwide.
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
Get instant alerts for recalls that affect you. Free forever.