Blood Pressure Medication Recalled Nationwide: Check Your Pills for These Lot Numbers
Thousands of bottles of a prescription blood pressure medication have been recalled across the United States following a manufacturing quality issue. The U.S. Food and Drug Administration (FDA) has classified the recall as Class II, prompting patients and healthcare professionals to pay close attention to medication labels and affected lot numbers.
The recall involves specific batches of a combination medication manufactured by Macleods Pharma USA. Patients who take blood pressure medication are encouraged to review their prescription bottles and contact their pharmacists if they have questions.
Which Blood Pressure Medication Has Been Recalled?
According to the FDA and reports published on November 2, 2026, Macleods Pharma USA initiated a voluntary recall of certain lots of:
Olmesartan Medoxomil
Amlodipine
Hydrochlorothiazide
These three medications are combined in a prescription tablet used to manage high blood pressure.
The recall affects a total of 3,744 bottles distributed nationwide in the United States.
The affected products include 3,528 bottles containing 30 tablets and 216 bottles containing 90 tablets.
Check These Recalled Lot Numbers
Patients should carefully review the prescription label to determine whether their medication matches the affected products.
Affected product information:
| Product Details | 30-Count Bottle | 90-Count Bottle |
|---|---|---|
| Medication | Olmesartan/Amlodipine/HCTZ | Olmesartan/Amlodipine/HCTZ |
| Strength | 40 mg/10 mg/12.5 mg | 40 mg/10 mg/12.5 mg |
| Lot Number | 12251163A | 12251163B |
| NDC | 33342-246-07 | 33342-246-10 |
| Expiration Date | May 31, 2027 | May 31, 2027 |
Important: The recall applies to these specific lots, not every blood pressure medication or every product containing these ingredients.
Why Was the Medication Recalled?
The FDA identified a manufacturing quality issue known as failed dissolution specifications.
Dissolution testing measures how a tablet breaks down and releases its active ingredients under controlled laboratory conditions.
When a medication fails this test, there may be concerns about how reliably its ingredients are released and absorbed by the body.
In this case, the quality issue raised concerns about whether the affected tablets would perform as expected.
The FDA classified the recall as Class II. This category indicates that using the affected product may cause temporary or medically reversible health consequences, while the probability of serious consequences is considered remote.
What Should Patients Do If They Have the Recalled Medication?
Anyone who believes they may have an affected bottle should take the recall seriously and contact their pharmacist or healthcare provider.
Here are some important steps:
Check the prescription label: Look for the medication name, manufacturer, lot number, and NDC.
Compare the information: Determine whether the bottle matches either recalled lot.
Contact a pharmacist: Ask for help confirming whether your specific prescription is affected.
Follow professional guidance: Ask your healthcare provider what to do about the affected medication and whether an alternative is needed.
Keep the packaging: Retain the bottle and prescription information until you receive instructions.
Patients should not independently stop or change prescribed blood pressure treatment because suddenly interrupting some medications can create additional health risks.
Why Blood Pressure Medication Safety Matters
High blood pressure, also known as hypertension, is a common health condition affecting millions of adults.
When blood pressure remains uncontrolled, it can increase the risk of serious health problems, including heart disease, stroke, and kidney complications.
Prescription medications play an important role in managing the condition.
That is why medication quality, proper manufacturing, and accurate labeling are essential parts of patient safety.
A recall does not necessarily mean every bottle of a particular medication is unsafe. In many cases, recalls involve specific manufacturing batches rather than an entire medication category.
How to Stay Updated on Medication Recalls
Patients can stay informed by following official FDA drug safety announcements and speaking with licensed healthcare professionals.
The FDA maintains public databases containing information about recalled medications, including affected manufacturers, lot numbers, recall classifications, and reasons for the action.
Regularly checking prescription labels and keeping medication information available can also help patients respond quickly when a recall is announced.
Staying informed, checking medication labels, and following trusted medical advice can help protect your health.
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