WASHINGTON, DC — The U.S. Food and Drug Administration has assigned a Class II designation to a nationwide recall of more than 3,700 bottles of blood pressure tablets made by Macleods Pharma USA, Inc. The recall was listed in the agency’s enforcement report on Oct. 26 and was first initiated on Oct. 7.
The affected medicine is a combination tablet used to manage high blood pressure: olmesartan medoxomil, amlodipine and hydrochlorothiazide. Consumers who take the drug should check their bottles carefully, especially if they have medication purchased in a 30-count or 90-count package from one of the two recalled lots.
Which bottles are included in the recall
The recall covers two specific products sold by Macleods Pharma USA. Both are the same strength, 40 mg/10 mg/12.5 mg, but they come in different bottle sizes and lot numbers.
The 30-count bottle has National Drug Code 33342-246-07, lot number 12251163A and an expiration date of May 31, 2027. The 90-count bottle has National Drug Code 33342-246-10, lot number 12251163B and the same expiration date.
FDA records indicate the recall is nationwide, so consumers in any state could have received the affected medicine. Patients should compare the label on their bottle against those details before taking their next dose.
Why FDA classified the recall as Class II
According to the FDA, the reason for the action is “failed dissolution specifications.” In practical terms, that means the tablets did not perform as expected during testing of how they break down in the body.
If a tablet does not dissolve properly, it may not work as intended to lower blood pressure. The FDA says a Class II recall is used when exposure to the product could cause temporary or medically treatable health effects, or when the chance of serious harm is considered very unlikely.
What patients should do before taking another dose
Anyone who has one of the recalled bottles should contact a health care provider promptly for guidance. A doctor or pharmacist can help determine whether the patient should keep taking the medicine, switch to another supply or obtain a replacement prescription.
The FDA warns patients not to stop any prescription medication without speaking to a clinician first. For people managing blood pressure, suddenly stopping treatment can create a separate health risk, so the safest next step is to confirm the bottle information and get medical advice.
What the combination medicine is used for
Olmesartan medoxomil, amlodipine and hydrochlorothiazide are combined in a single tablet to help control high blood pressure. The medicine brings together three ingredients that work in different ways to lower pressure in the arteries.
Because the drug is prescribed for a chronic condition, many patients may have it in their regular home medication supply. That makes label checks especially important, since a recalled bottle could be mixed in with other long-term prescriptions.
How to identify the recalled product quickly
The easiest way to confirm the product is to check the strength, bottle count, NDC number, lot number and expiration date together. The recalled tablets are 40 mg/10 mg/12.5 mg and carry either lot 12251163A or lot 12251163B.
Patients should also note that the recall applies to bottles of 30 tablets and 90 tablets, both with a May 31, 2027 expiration date. If the label matches those details, the bottle is part of the recall and should be reviewed with a health care professional before any further use.
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