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FDA Class II Recall Issued for Thousands of Blood Pressure Medication Bottles

Macleods Pharma USA is recalling certain lots of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets after they failed to meet federal quality standards.

By Hermes-Vector AI Desk

Checked against 2 sourcesfoxbusiness.comprevention.com
Illustration for: FDA Class II Recall Issued for Thousands of Blood Pressure Medication Bottles

In brief

  • Macleods Pharma USA is recalling 3,528 30-count bottles and 216 90-count bottles of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets.
  • The FDA classified the recall as Class II because the medication failed dissolution specifications, meaning the pills may not dissolve as required.
  • The affected medication lots have an expiration date of May 31, 2027.
  • Consumers are advised to contact their prescribing doctor before discontinuing use of the medication.

FDA Class II Recall Issued for Thousands of Blood Pressure Medication Bottles

The U.S. Food and Drug Administration (FDA) has issued a nationwide recall for thousands of bottles of blood pressure medication after the products failed to meet federal quality standards, according to the FDA.

Recall Details

Macleods Pharma USA, Inc. initiated a voluntary recall on October 7, which the FDA classified on October 26 as a Class II recall. A Class II designation means that use of the affected medication "may cause temporary or medically reversible adverse health consequences," though the likelihood of serious health consequences is considered remote, according to the FDA.

The FDA stated the reason for the recall is "failed dissolution specifications," which means the pills did not dissolve as required during testing. According to Prevention, this could mean the drug may be ineffective because the active ingredients may not release inside the body at the proper rate.

Affected Products

The recall involves specific lots of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets (a generic of the brand Tribenzor). The affected products include:

Product DescriptionLot NumberNDCCountExpiration Date
Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets 40 mg/10 mg/12.5 mg12251163A33342-246-0730-countMay 31, 2027
Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets 40 mg/10 mg/12.5 mg12251163B33342-246-1090-countMay 31, 2027

Consumer Guidance

If you have these medications, you should check your prescription bottles for the lot number and National Drug Code (NDC) listed above.

While the FDA has not issued specific instructions to consumers, Prevention reports that if you have any of the recalled medications, you should contact the doctor who prescribed them before discontinuing use. If you have been taking the recalled pills and have health concerns, you should talk with your doctor.

Why it matters

This recall follows a similar incident in September when India-based Inventia Healthcare Ltd. recalled 13,567 bottles of 25-milligram chlorthalidone tablets after they also failed dissolution testing, according to the FDA.

Sources

This article was drafted with AI assistance and checked against the sources above. Company claims are reported as claims. Cover image is AI-generated.

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