Quick Facts at a Glance
- Recall Date
- July 21, 2025
- Hazard Level
- HIGH
- Brands
- Amlodipine and Olmesartan Medoxomil, Ascend Laboratories, Alkem Laboratories
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- Amlodipine and Olmesartan Medoxomil, Ascend Laboratories, Alkem Laboratories
- Product type
- Amlodipine and Olmesartan Medoxomil Tablets
- Model numbers
- Lot 23121560, Exp 4/30/2026
- UPC codes
- 67877-499, 67877-500, 67877-501, 67877-502, 67877-499-30, 67877-499-90, 67877-500-30, 67877-500-90 +4 more
- Sizes
- 30-count bottle
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 21, 2025
Reported by FDA DRUG
August 20, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Dissolution Specifications: low dissolution results
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Ascend Laboratories, LLC or your healthcare provider for guidance. Notification method: Letter
About This Product
Amlodipine and Olmesartan Medoxomil is a prescription antihypertensive combination used to treat high blood pressure. It lowers blood pressure by relaxing blood vessels and reducing workload on the heart.
Why This Is Dangerous
Low dissolution can impair drug release, potentially reducing efficacy and allowing continued high blood pressure.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Patients may experience suboptimal blood pressure control if the drug fails to dissolve properly.
Practical Guidance
How to identify if yours is affected
- Check bottle for Lot 23121560 and Exp 4/30/2026
- Verify NDC 67877-501-30 on packaging
- Confirm 30-count bottle and Rx Only labeling
Where to find product info
NDC on bottle label; FDA recall page and enforcement report D-0576-2025
What timeline to expect
Refund or replacement timelines vary; expect several weeks after processing
If the manufacturer is unresponsive
- Escalate with patient advocacy groups
- File a complaint with FDA/CMC if needed
- Seek pharmacist guidance for alternatives
How to prevent similar issues
- Verify drug dissolution claims with manufacturer or pharmacist
- Check for recalls before refilling antihypertensive medications
- Prefer manufacturers with robust dissolution testing and batch controls
Documentation advice
Keep bottle, purchase receipts, recall notices, and all correspondence with the manufacturer
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Product: Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, 30-count bottle, Rx Only. Manufacturer: Alkem Laboratories Ltd., India. Distributor: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-501-30. Lot: 23121560. Exp: 4/30/2026. Quantity: 8,568 bottles. Sold nationwide in the USA.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Distributed nationwide in the USA
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.