Medications & Supplements/Prescription Drugs

Ascend Laboratories LLC: Olmesartan Medoxomil Tablets Recalled for Current Good Manufacturing Violations

Agency Publication Date: February 6, 2020

Summary

Ascend Laboratories LLC is recalling 192 bottles of Olmesartan Medoxomil (20 mg), a prescription blood pressure medication, due to manufacturing deviations. Specifically, the tablets were made using an alternate source of active ingredients that had not yet been approved by the FDA at the time of release. This recall affects 90-count bottles that were distributed nationwide throughout the United States.

Risk

The use of an unapproved ingredient source means the medication's quality, safety, and effectiveness cannot be fully guaranteed by the approved manufacturing standards. While no specific injuries or adverse health effects have been reported, using medication that deviates from established manufacturing processes may result in unpredictable performance of the drug.

What You Should Do

Check your medication bottle for Olmesartan Medoxomil Tablets 20 mg (NDC 67877-446-90) to see if it is from the affected lot.
Locate the lot number and expiration date on the side of the label to confirm if your bottle is affected: Lot number 19122552 with an expiration date of 7/31/2021.
If you have an affected bottle, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking the medication.
Return any remaining tablets from the affected lot to your pharmacy for a refund and contact Ascend Laboratories LLC for further guidance.
For more information or to report concerns, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare consultation and pharmacy return.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Olmesartan Medoxomil Tablets 20 mg (90 Tablets per Bottle)

Model:

NDC 67877-446-90

Recall #: D-0828-2020

Lot Numbers:

19122552 (Exp 7/31/2021)

Date Ranges: Expiration 7/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84818

Status: Resolved

Manufacturer: Ascend Laboratories LLC

Sold By: pharmacies nationwide

Manufactured In: India, United States

Units Affected: 192 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 · 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.

Summary

Risk

What You Should Do

Check your medication bottle for Olmesartan Medoxomil Tablets 20 mg (NDC 67877-446-90) to see if it is from the affected lot.

Locate the lot number and expiration date on the side of the label to confirm if your bottle is affected: Lot number 19122552 with an expiration date of 7/31/2021.

If you have an affected bottle, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking the medication.

Return any remaining tablets from the affected lot to your pharmacy for a refund and contact Ascend Laboratories LLC for further guidance.

For more information or to report concerns, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.