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Blood Pressure Drug Recalled Because Tablets May Not Dissolve Properly

More than 3,700 bottles of generic blood pressure medication are included in the nationwide recall

3-minute read

AARP

Reviewed by

Aaron Kassraie

Published November 03, 2026

Stethoscope, blood pressure monitor and medication on a pink background.

Getty Images

Key takeaways

Macleods Pharma USA recalled 3,744 bottles of a combination blood pressure medication distributed nationwide.
The tablets may not dissolve properly, according to the FDA recall listing.
Patients should check the lot number on their medication and contact their pharmacist or health care provider before stopping treatment.

More than 3,700 bottles of a prescription blood pressure medication have been recalled nationwide because the tablets may not dissolve properly, according to a Food and Drug Administration (FDA) recall notice.

The voluntary recall involves certain lots of a generic combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide distributed by Macleods Pharma USA. The medication contains the same three active ingredients as the brand-name drug Tribenzor. The FDA recall notice does not list Tribenzor-branded medication.

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The FDA classified the recall as Class II on Oct. 26, meaning the affected medication may cause temporary or medically reversible health problems, while the risk of serious harm is considered remote.

Which blood pressure medication was recalled?

The recall covers tablets containing 40 mg of olmesartan medoxomil, 10 mg of amlodipine and 12.5 mg of hydrochlorothiazide.

The prescription medication was manufactured by Macleods Pharmaceuticals Ltd. in Daman, India, for Macleods Pharma USA in Princeton, New Jersey.

A total of 3,744 bottles are affected:

30-count bottles

Product: Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, 40 mg/10 mg/12.5 mg
NDC: 33342-246-07
Lot number: 12251163A
Expiration date: May 31, 2027
Quantity recalled: 3,528 30-count bottles

190-count bottles

Product: Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, 40 mg/10 mg/12.5 mg
NDC: 33342-246-10
Lot number: 12251163B
Expiration date: May 31, 2027
Quantity recalled: 216 90-count bottles

The products were distributed nationwide in the United States.

What should patients do?

Check your prescription bottle to see whether the medication name, manufacturer and lot number match the recalled product.

Do not stop taking a prescribed blood pressure medication without first talking to your doctor or pharmacist. The FDA says patients can generally continue using medication involved in a Class II recall unless the recalling company or the agency directs them otherwise.

If your medication is included in the recall:

Contact your pharmacist or prescribing health care provider for guidance.
Ask whether you should continue taking the medication while arranging a replacement.
Follow any return or disposal instructions provided by your pharmacy.If your medication was transferred into an orange prescription bottle, the manufacturer’s lot number may not appear on its label. Contact the pharmacy that filled the prescription and ask whether your medication came from one of the recalled lots.

Patients and health care professionals can report side effects or medication-quality problems through the FDA’s MedWatch Safety Information and Adverse Event Reporting Program or by calling 800-FDA-1088.