HIGH

Ascend Laboratories Amlodipine and Olmesartan Medoxomil Recall for Low Dissolution 8,568 Bottles in

Ascend Laboratories recalls 8,568 bottles of Amlodipine and Olmesartan Medoxomil tablets due to failed dissolution specifications. The recall covers products manufactured by Alkem Laboratories in India and distributed nationwide in the USA. The defect involves low dissolution results. Stop use immediately and contact Ascend Laboratories for guidance.

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

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

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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

  1. Check bottle for Lot 23121560 and Exp 4/30/2026
  2. Verify NDC 67877-501-30 on packaging
  3. 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

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

  • 8,568 bottles recalled
  • NDC 67877-501-30
  • Lot 23121560
  • Exp 4/30/2026
  • Distributed nationwide in the USA

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 Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPETS
Injury Types
POISONINGOTHER

Product Details

Model Numbers
Lot 23121560
Exp 4/30/2026
UPC Codes
67877-499
67877-500
67877-501
+9 more
Affected States
ALL
Report Date
August 20, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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