HIGH

Ascend Laboratories Recalls Amlodipine and Olmesartan Tablets Over Dissolution Issues

Ascend Laboratories recalled 8,568 bottles of Amlodipine and Olmesartan Medoxomil Tablets on July 21, 2025. The recall follows reports of low dissolution results, impacting the drug's effectiveness. Consumers should stop using the product and seek guidance immediately.

Quick Facts at a Glance

Recall Date
July 21, 2025
Hazard Level
HIGH
Brands
Amlodipine and Olmesartan Medoxomil, Ascend Laboratories
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

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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Product Details

The recall involves Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, sold in 30-count bottles. The product carries NDC 67877-501-30 and has an expiration date of April 30, 2026.

The Hazard

The recalled tablets failed dissolution specifications, which may affect their intended therapeutic effect. Low dissolution results can lead to inadequate treatment of hypertension.

Reported Incidents

No specific injuries or adverse events are reported related to this recall. However, the risk of ineffective treatment poses a significant health concern.

What to Do

Consumers should stop using the recalled tablets immediately. Contact Ascend Laboratories, LLC or a healthcare provider for further instructions.

Contact Information

For assistance, call Ascend Laboratories, LLC at their customer service number. More information is available on the FDA website.

Key Facts

  • Recall date: July 21, 2025
  • Reported date: August 20, 2025
  • Class II recall due to health risks
  • Distributed nationwide in the USA

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

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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