Medications & Supplements/Prescription Drugs

Boehringer Ingelheim Pharmaceuticals, Inc.: Micardis (Telmisartan) Tablets Recalled for Subpotency

Agency Publication Date: May 28, 2021

Summary

Approximately 15,198 bottles of Micardis (telmisartan) 80 mg tablets have been recalled because the medication is subpotent, meaning it may contain less of the active ingredient than required. If a patient takes subpotent blood pressure medication, their high blood pressure may not be adequately controlled, which can lead to serious health issues. This recall affects 30-count bottles with specific lot numbers that were distributed to pharmacies across 10 states and Puerto Rico. Consumers should not stop taking their medication before speaking with a doctor or pharmacist to arrange for a safe replacement.

Risk

The drug is subpotent, which means it fails to provide the full therapeutic dose of telmisartan required to manage hypertension. This can lead to uncontrolled high blood pressure and increases the risk of related cardiovascular complications.

What You Should Do

Check your prescription bottle label to see if you have Micardis (telmisartan) 80 mg Tablets in 30-count bottles.
Locate the Lot number and expiration date on the side of the bottle or the outer carton. This recall specifically affects Lot #860412 with an expiration date of SEPT 2022.
Check the NDC (National Drug Code) number on the packaging to see if it matches 0597-0041-37.
If you have the affected medication, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement medication.
Do not stop taking your blood pressure medication without first consulting a healthcare professional, as stopping suddenly can cause a dangerous spike in blood pressure.
Return any unused product from the affected lot to your pharmacy for a refund and contact Boehringer Ingelheim Pharmaceuticals, Inc. for further guidance.
For additional questions or to report a reaction, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider and return to pharmacy.

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

Affected Products

Product: Micardis Tablets (telmisartan Tablets) 80 mg (30-count bottle)

Model:

NDC 0597-0041-37

Recall #: D-0600-2021

Lot Numbers:

860412 (Exp SEPT 2022)

Date Ranges: SEPT 2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87856

Status: Resolved

Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 15,198 bottles (30 tablets per bottle)

Distributed To: Arkansas, Colorado, Connecticut, Louisiana, North Carolina, North Dakota, New Hampshire, New Jersey, Ohio, Pennsylvania, Puerto Rico

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

What You Should Do

Check your prescription bottle label to see if you have Micardis (telmisartan) 80 mg Tablets in 30-count bottles.

Locate the Lot number and expiration date on the side of the bottle or the outer carton. This recall specifically affects Lot #860412 with an expiration date of SEPT 2022.

Check the NDC (National Drug Code) number on the packaging to see if it matches 0597-0041-37.

If you have the affected medication, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement medication.

Do not stop taking your blood pressure medication without first consulting a healthcare professional, as stopping suddenly can cause a dangerous spike in blood pressure.

Return any unused product from the affected lot to your pharmacy for a refund and contact Boehringer Ingelheim Pharmaceuticals, Inc. for further guidance.

For additional questions or to report a reaction, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.