WASHINGTON, DC — The Food and Drug Administration has announced a Class II recall for more than 3,700 bottles of a blood pressure medication made by Macleods Pharma USA, Inc. The agency says the action affects two lots of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets sold nationwide.
The recall was initiated on Oct. 7 and was later posted by the FDA in an enforcement report dated Oct. 26. Regulators said the tablets failed dissolution specifications during testing, which means they may not break down in the body the way they should.
Why the FDA says these tablets were recalled
Dissolution testing checks how a tablet dissolves after it is taken. When a medication does not meet those standards, it may not release its active ingredients as intended.
In this case, the FDA says the failure could mean the blood pressure medicine may not work effectively enough for patients who depend on it to control their condition. The agency classified the recall as Class II, which indicates a situation where exposure to the product could cause temporary or medically treatable health effects, while serious health consequences are considered unlikely.
That classification does not mean the tablets are expected to cause a severe medical emergency. It does mean the products did not meet quality standards and should be checked carefully by anyone who has them at home.
Which bottle sizes and lot numbers are included in the recall
The recall includes two bottle sizes of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets in the 40 mg/10 mg/12.5 mg strength. One recalled package is a 30-count bottle with NDC 33342-246-07 and lot number 12251163A.
The other is a 90-count bottle with NDC 33342-246-10 and lot number 12251163B. Both recalled lots carry an expiration date of May 31, 2027.
Anyone who takes this medicine should compare the NDC number, lot number, and expiration date on the label with the recall information. The FDA says the recall covers specific lots, not every bottle of the same medication name.
What patients should do if they have the recalled medicine
The FDA advises patients to contact their health care provider right away for guidance. That guidance may include whether to keep taking the medication temporarily or request a replacement prescription.
Patients should not stop taking any blood pressure medicine without first speaking with a doctor. Suddenly stopping treatment can create health risks of its own, especially for people who rely on the medication to manage an ongoing condition.
Those who find a bottle matching the recalled lot should follow the instructions from their medical provider or pharmacist and should not assume the tablets are safe to keep using just because no side effects are obvious.
Why blood pressure patients should check their bottles now
Blood pressure medication is often taken daily and for long periods, so even a quality problem limited to a narrow set of lots can affect many patients before it is caught. That makes label checks important whenever the FDA announces a recall tied to a dosing or manufacturing issue.
The concern here is not contamination or an immediate toxic reaction. Instead, it is whether the tablets perform as expected when a patient takes them.
For people managing hypertension, the effectiveness of each dose matters. If a tablet does not dissolve properly, it may not provide the level of control the patient and their clinician expect.
How the recall fits into the FDA enforcement process
The FDA’s enforcement report is the federal notice used to document recalls and related actions. In this case, it shows the agency has already assigned the recall a Class II designation and identified the affected product details.
Consumers can use that information to match the medicine in their possession against the recalled lots. Pharmacists and health care providers can also help confirm whether a prescription is included.
Anyone who has questions about a bottle should have the packaging nearby when they call, since the NDC number, lot number, and expiration date are the key identifiers in the recall notice.
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