HIGHFDA DRUG

Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC...

Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
May 5, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
May 5, 2026
Hazard Level
HIGH
Brands
AMLODIPINE AND OLMESARTAN MEDOXOMIL, Ascend Laboratories, LLC
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

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 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, LLC
Model numbers
Lot: 24123460, Expires: October 31, 2027.
UPC codes
67877-499, 67877-500, 67877-501, 67877-502, 67877-499-30, 67877-499-90, 67877-500-30, 67877-500-90 +4 more
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    May 5, 2026

  2. Reported by FDA DRUG

    June 10, 2026

  3. RecallRadar source check

    June 16, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

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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Full Description

Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.. Generic: AMLODIPINE AND OLMESARTAN MEDOXOMIL; Brand: AMLODIPINE AND OLMESARTAN MEDOXOMIL. Reason: Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications. Classification: Class II. Quantity: 15,696 x 30's bottles. Distribution: U.S.A. Nationwide

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Lot: 24123460
Expires: October 31
2027.
UPC Codes
67877-499
67877-500
67877-501
+9 more
Affected States
ALL
Report Date
June 10, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE