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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Amlodipine and Olmesartan Medoxomil Tablets Recalled for Low Dissolution

Agency Publication Date: August 8, 2025
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Summary

Ascend Laboratories, LLC is recalling 8,568 bottles of Amlodipine and Olmesartan Medoxomil Tablets (5 mg/ 40 mg) because the medication failed dissolution testing. This defect means the drug may not break down properly in the body, which can prevent the active ingredients from working effectively to manage blood pressure. If you are taking this medication, you should contact your doctor or pharmacist to discuss your treatment options and verify if your bottle is part of the recall.

Risk

Low dissolution results mean the medication may not be fully absorbed by the body, potentially leading to poorly controlled blood pressure and an increased risk of related cardiovascular issues. No incidents or injuries have been reported to date.

What You Should Do

  1. This recall affects Amlodipine and Olmesartan Medoxomil Tablets (5 mg/ 40 mg) sold in 30-count bottles under NDC 67877-501-30, specifically Lot 23121560 with an expiration date of 4/30/2026.
  2. If you have health concerns, contact your healthcare provider or pharmacist.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Ascend Laboratories, LLC for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Amlodipine and Olmesartan Medoxomil Tablets (30-count bottle)by Ascend Laboratories, LLC
Variants: 5 mg/ 40 mg, Tablet
Lot Numbers:
23121560 (Exp 4/30/2026)
NDC:
67877-501-30

Manufactured by Alkem Laboratories Ltd., India; Distributed by Ascend Laboratories, LLC, Parsippany, NJ.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97293
Status: Active
Manufacturer: Ascend Laboratories, LLC
Sold By: Pharmacies nationwide
Manufactured In: India
Units Affected: 8,568 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.