Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brands
- Viorele, Glenmark Pharmaceuticals
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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
- Viorele, Glenmark Pharmaceuticals
- Product type
- Combined oral contraceptive pill
- Model numbers
- Batch 20230733, Exp October 2025
- UPC codes
- 68462-318, 68462-318-29
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 3, 2025
Reported by FDA DRUG
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Impurities/Degradation Specifications
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
Why This Is Dangerous
The recall is due to impurities and degradation specifications. Impurities or degradation products could cause adverse effects or reduced effectiveness.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers may face treatment delays or require medical guidance if affected; no injuries reported yet.
Practical Guidance
How to identify if yours is affected
- Check your prescription bottle for NDC 68462-318-29
- Look for batch 20230733 on the packaging
- Verify expiration date October 2025
Where to find product info
NDC on label and carton, along with batch and expiration details
What timeline to expect
Not specified in the recall notice
If the manufacturer is unresponsive
- Document attempts to contact Glenmark or healthcare providers
- Consider filing a timely report with the FDA if the company is unresponsive
How to prevent similar issues
- Verify NDC and lot numbers before dispensing or taking a new prescription
- Consult your clinician before switching to another contraceptive
- Keep recall letters and packaging for reference
Documentation advice
Keep the recall notification, packaging, and all correspondence with pharmacists or doctors.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Product: Viorele Desogestrel and Ethinyl Estradiol USP 0.15 mg/0.02 mg and Ethinyl Estradiol USP 0.01 mg; Packaging: 3 blisters each containing 28 tablets; Regimen: Rx only, 28-day; NDC: 68462-318-29; Batch: 20230733; Exp: October 2025; Manufacturer: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430; Distribution: US Nationwide; Quantity: 26,928 packs.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US nationwide distribution
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.