Rachel V Thomas

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US FDA Recalls Thousands Of Blood Pressure Drugs Over Excess Drug Levels, Failed Quality Tests

The US Food and Drug Administration (<span>FDA</span>) has announced nationwide recalls of two blood pressure medications over concerns about excess drug levels and manufacturing quality failures.

The recalls involve combination medications prescribed to manage hypertension. The FDA cited concerns that one medication may contain more of an active ingredient than specified, while the other failed quality tests that assess how quickly the drug dissolves in the body.

<h2>Which Blood Pressure Medications Have Been Recalled?</h2>

Also read: <a href="https://www.healthandme.com/health-news/us-fda-recalls-india-made-bp-drug-for-the-second-time-in-3-months-heres-why-article-156243338" data-type="tilCustomLink">US FDA Recalls India-Made BP Drug For The Second Time In 3 Months: Here's Why</a>

<strong>1. <span rel="noindex">Viatris</span> blood pressure medication: 21,620 bottles recalled</strong>

The FDA has announced a Class III recall of Viatris Inc.'s combination <span>telmisartan</span> and amlodipine tablets because they may contain more telmisartan than specified.

The Class III recall means the use of the affected product is not likely to cause adverse health consequences.

The FDA did not specify how much additional telmisartan the tablets may contain. However, the National Library of Medicine warns that an overdose of this medication could cause low blood pressure, dizziness or a rapid heart rate.

In total, 21,620 bottles of the medication have been recalled.

The recall covers 30-count bottles of telmisartan and amlodipine tablets (40 mg/5 mg) with the following lot codes:

<ul><li>Lots 3228113, 3228114 and 3228115, with an expiration date of October 31.</li><li>Lots 3228120 and 3228121, with an expiration date of November 30.</li></ul>

<strong>2. <span rel="noindex">Macleods Pharmaceuticals</span> blood pressure medication: 3,744 bottles recalled</strong>

The FDA has also recalled 3,744 bottles of another combination blood pressure medication manufactured by Macleods Pharmaceuticals.

The company first initiated the recall on October 7 over "failed dissolution specifications." This means the medication may not release its active ingredients at the required rate after being taken.

If a drug does not dissolve properly, its active ingredients may not be absorbed as intended, potentially affecting its effectiveness. In this case, the medication may not lower blood pressure as expected.

On October 26, the FDA classified the recall as Class II. This means using the affected product may cause temporary or medically reversible adverse health consequences, although serious health problems are unlikely.

<ul><li><span rel="noindex">Olmesartan Medoxomil</span>, Amlodipine and Hydrochlorothiazide Tablets (40 mg/10 mg/12.5 mg), 30-count: 3,528 bottles; NDC 33342-246-07; lot number 12251163A; expiration date May 31, 2027.</li><li>Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40 mg/10 mg/12.5 mg), 90-count: 216 bottles; NDC 33342-246-10; lot number 12251163B; expiration date May 31, 2027.</li></ul>

<strong>Read More</strong>: <a href="https://www.healthandme.com/health-news/glp-1-drug-mounjaro-zepbound-ingredient-recalled-in-us-over-sterility-concerns-article-156376227" data-type="tilCustomLink">Mounjaro, Zepbound Ingredient Recalled In US Over Sterility Concerns</a>

<h2>What Should You Do If You Have The Recalled Medication? </h2>

The FDA advises patients not to stop taking their medication without consulting their healthcare provider, as abruptly discontinuing blood pressure treatment may pose additional health risks.

If you have any of the affected products, contact your doctor or pharmacist for guidance on whether you should continue taking them or switch to an alternative.

For the Macleods Pharmaceuticals medication, the FDA did not issue a separate news release. Its enforcement report states that letters were sent to notify businesses and individuals who may have the affected products.

Patients should consult their healthcare provider before making any changes to their medication routine.

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US FDA Recalls

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The US Food and Drug Administration (FDA) has announced nationwide recalls of two blood pressure medications over concerns about excess drug levels and manufacturing quality failures.The recalls involve combination medications prescribed to manage hypertension. The FDA cited concerns that one medication may contain more of an active ingredient than specified, while the other failed quality tests that assess how quickly the drug dissolves in the body.Which Blood Pressure Medications Have Been Recalled?Also read: US FDA Recalls India-Made BP Drug For The Second Time In 3 Months: Here's Why1. Viatris blood pressure medication: 21,620 bottles recalledThe FDA has announced a Class III recall of Viatris Inc.'s combination telmisartan and amlodipine tablets because they may contain more telmisartan than specified.The Class III recall means the use of the affected product is not likely to cause adverse health consequences.The FDA did not specify how much additional telmisartan the tablets may contain. However, the National Library of Medicine warns that an overdose of this medication could cause low blood pressure, dizziness or a rapid heart rate.In total, 21,620 bottles of the medication have been recalled.The recall covers 30-count bottles of telmisartan and amlodipine tablets (40 mg/5 mg) with the following lot codes:Lots 3228113, 3228114 and 3228115, with an expiration date of October 31.Lots 3228120 and 3228121, with an expiration date of November 30.2. Macleods Pharmaceuticals blood pressure medication: 3,744 bottles recalledThe FDA has also recalled 3,744 bottles of another combination blood pressure medication manufactured by Macleods Pharmaceuticals.The company first initiated the recall on October 7 over "failed dissolution specifications." This means the medication may not release its active ingredients at the required rate after being taken.If a drug does not dissolve properly, its active ingredients may not be absorbed as intended, potentially affecting its effectiveness. In this case, the medication may not lower blood pressure as expected.On October 26, the FDA classified the recall as Class II. This means using the affected product may cause temporary or medically reversible adverse health consequences, although serious health problems are unlikely.The recall covers:Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40 mg/10 mg/12.5 mg), 30-count: 3,528 bottles; NDC 33342-246-07; lot number 12251163A; expiration date May 31, 2027.Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40 mg/10 mg/12.5 mg), 90-count: 216 bottles; NDC 33342-246-10; lot number 12251163B; expiration date May 31, 2027.Read More: Mounjaro, Zepbound Ingredient Recalled In US Over Sterility ConcernsWhat Should You Do If You Have The Recalled Medication? The FDA advises patients not to stop taking their medication without consulting their healthcare provider, as abruptly discontinuing blood pressure treatment may pose additional health risks.If you have any of the affected products, contact your doctor or pharmacist for guidance on whether you should continue taking them or switch to an alternative.For the Macleods Pharmaceuticals medication, the FDA did not issue a separate news release. Its enforcement report states that letters were sent to notify businesses and individuals who may have the affected products.Patients should consult their healthcare provider before making any changes to their medication routine.

us fda recalls thousands of blood pressure drugs over excess drug levels, failed quality tests

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