# FDA Announces Nationwide Recall of Over 580,000 Bottles of Blood Pressure Medication Due to Cancer-Causing Chemical
A major health alert has been issued for patients managing high blood pressure. The U.S. Food and Drug Administration (FDA) has announced a significant nationwide recall impacting over 580,000 bottles of a common blood pressure medication. The recall, initiated by the pharmaceutical company Aurobindo Pharma USA, Inc., targets specific lots of Quinapril and Hydrochlorothiazide Tablets due to the presence of a potentially cancer-causing chemical. If you or a loved one takes this medication, it’s crucial to understand the details of this recall, the potential risks, and the immediate steps you should take. This **FDA recall of blood pressure medication** is a serious event, but with the right information, you can navigate it safely and protect your health.
This guide will break down everything you need to know: which specific medication is affected, why it’s being recalled, and most importantly, what you should do next.
## What Exactly Is Being Recalled?
The recall is focused on a specific combination drug used to treat hypertension (high blood pressure). Understanding the details can help you quickly determine if your prescription is affected.
### The Specific Medication: Quinapril and Hydrochlorothiazide Tablets
The drug at the center of this recall is **Quinapril and Hydrochlorothiazide Tablets USP**, specifically in the 20mg/12.5mg dosage. This medication combines two active ingredients: Quinapril, an ACE inhibitor that relaxes blood vessels, and Hydrochlorothiazide, a diuretic (or “water pill”) that helps the body get rid of excess salt and water. Together, they effectively lower blood pressure.
The recall was voluntarily initiated by the manufacturer, Aurobindo Pharma USA, Inc., and affects a single lot number. Here are the key identifiers to check on your prescription bottle:
* **Product:** Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg
* **Lot Number:** QE2021005-A
* **Expiration Date:** 01/2023
* **Packaging:** 90-count bottles
* **NDC Number:** 65862-162-90
This lot was distributed nationwide to wholesalers, distributors, and retailers from May 2021 through February 2022. While the expiration date has passed, it is possible that some patients may still have bottles from this lot in their medicine cabinets.
### Why Is This Medication Being Recalled? The Nitrosamine Concern
The reason for the recall is the detection of an impurity called **N-nitroso-quinapril**. This substance belongs to a class of chemicals known as nitrosamines. While nitrosamines are common in the environment and found in low levels in water and foods like cured meats and grilled vegetables, long-term exposure to levels above what is considered safe can increase the risk of cancer.
The FDA and other global health regulators have set strict acceptable daily intake limits for these impurities in pharmaceutical products. During testing, Aurobindo Pharma discovered that this specific lot of their Quinapril and Hydrochlorothiazide tablets contained N-nitroso-quinapril at a level that exceeds the FDA’s acceptable limit. The recall is a precautionary measure to prevent patient exposure to this elevated level of the potential carcinogen.
## Should You Stop Taking Your Medication Immediately?
This is the most critical question for any patient taking this medication, and the answer from the FDA and medical professionals is a resounding **NO.**
### The Dangers of Abruptly Stopping Blood Pressure Medication
Hypertension is a serious medical condition. Suddenly stopping your prescribed medication can lead to a rapid, uncontrolled spike in blood pressure. This can significantly increase your immediate risk of severe health events, including:
* Heart attack
* Stroke
* Kidney failure
* Heart failure
The immediate danger posed by stopping your medication is far greater than the potential long-term risk associated with the nitrosamine impurity found in the recalled lot. Patient safety is the top priority, and that includes maintaining control over your blood pressure.
### What You Should Do Instead: A Step-by-Step Guide
If you believe you may have the affected medication, follow these clear steps to ensure your health and safety:
1. **Check Your Prescription Bottle:** Look at your bottle of Quinapril and Hydrochlorothiazide. Find the manufacturer (Aurobindo Pharma), the dosage (20mg/12.5mg), and the lot number. Compare it to the recalled lot: **QE2021005-A**.
2. **Contact Your Pharmacist:** Your pharmacist is an excellent resource. They can confirm if the medication you received is part of the recall. They can also look at your prescription history to see if you were ever dispensed this specific lot.
3. **Consult Your Doctor:** This is the most important step. Contact your prescribing physician immediately. Inform them that your medication may be part of the recall. Your doctor will be able to prescribe a safe alternative from a different manufacturer or a different lot that is not affected. They may also decide to switch you to a different type of blood pressure medication altogether.
4. **Continue Medication Until You Have a Replacement:** Do not stop taking the recalled tablets until you have the replacement prescription in hand. Your doctor will guide you on how to make the switch safely.
## Is This Recall Part of a Larger Trend?
If this news sounds familiar, you’re not mistaken. This **FDA recall of blood pressure medication** is the latest in a series of similar recalls over the past few years related to nitrosamine impurities.
Several other common medications for blood pressure and heartburn, including Valsartan, Losartan, and Metformin, have faced recalls from various manufacturers for the same reason. These events have highlighted a systemic issue within the global pharmaceutical manufacturing supply chain.
Nitrosamine impurities can form unintentionally during the drug manufacturing process due to specific chemical reactions under certain conditions. In response, the FDA has significantly increased its scrutiny and implemented more rigorous testing requirements for manufacturers. The agency is actively working with drug makers to understand the root causes of nitrosamine formation and to ensure that medications sold in the U.S. are free from unsafe levels of these impurities. This ongoing vigilance, while leading to more recalls, is ultimately a positive step toward a safer drug supply.
## Key Takeaways and Final Advice
Navigating a medication recall can be stressful, but it’s important to focus on the facts and take calm, decisive action. Here is a summary of the most important points from this recall announcement:
* **The Recall:** Aurobindo Pharma has recalled one lot (**QE2021005-A**) of Quinapril and Hydrochlorothiazide Tablets 20mg/12.5mg due to an elevated level of a potential carcinogen, N-nitroso-quinapril.
* **Do Not Panic:** The risk is associated with long-term exposure, not short-term use.
* **Do Not Stop Your Medication:** The immediate risk of a heart attack or stroke from uncontrolled high blood pressure is far greater than the potential risk from the impurity.
* **Take Action:** Check your prescription bottle immediately. Contact your doctor and pharmacist to confirm if you are affected and to arrange for a safe alternative medication.
Your health is paramount. By staying informed and working closely with your healthcare providers, you can ensure your blood pressure remains managed safely and effectively.
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