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Macleods Pharma USA recalled 3,744 bottles of a combination blood pressure medication distributed nationwide after the tablets failed dissolution specifications in testing. The FDA classified the recall as Class II; the affected lots expire May 31, 2027. Patients should check the lot and NDC on their bottles and contact a pharmacist or prescriber about what to do.
Macleods Pharma USA has recalled 3,744 bottles of a combination blood pressure medication distributed nationwide after the tablets failed dissolution specifications, according to the U.S. Food and Drug Administration. The agency classified the action as a Class II recall, a category for products that may cause temporary or medically reversible health effects, while the likelihood of serious harm is considered remote.
The recall covers two lots of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, a prescription combination used to treat high blood pressure. The company is recalling 3,528 bottles of 30 tablets from lot 12251163A and 216 bottles of 90 tablets from lot 12251163B. Both lots have an expiration date of May 31, 2027.
Consumers can compare their bottle’s lot number and National Drug Code with the recalled products. The 30-count bottles carry NDC 33342-246-07; the 90-count bottles carry NDC 33342-246-10. The reported reason is “failed dissolution specifications,” meaning the tablets did not meet requirements for how they dissolve during testing. The source report does not provide test results or explain the specific performance of either lot.
Macleods Pharma USA initiated the recall on October 7, and the FDA classified it on October 26. The recall affects products distributed nationwide and remains ongoing, according to the report. Fox Business said it could not immediately reach the New Jersey-based company for comment.
Checking Prescriptions for Affected Lots
The recall concerns a medication taken to manage high blood pressure, so patients who use the combination product may need to determine whether their prescription came from one of the affected lots. A failure in dissolution testing indicates a quality specification was not met; it does not, by itself, establish that every tablet in a recalled lot will cause harm or show what effect a particular patient might experience.
The FDA’s Class II classification gives a general indication of the agency’s risk assessment: temporary or medically reversible adverse health consequences are possible, while serious consequences are considered unlikely. That classification is not a patient-specific assessment. People who find a matching lot should ask a pharmacist or prescriber how to proceed rather than making a medication change based only on the recall notice.
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Recent Recalls Involving Dissolution Tests
The FDA reason cited in this recall, failed dissolution specifications, relates to how a medication performs in a laboratory test of its ability to dissolve. The source report does not say whether the failure involved a particular batch characteristic, how far the results were outside the specification, or whether complaints or injuries were reported.
The report also notes a separate recall announced in September: India-based Inventia Healthcare Ltd. recalled 13,567 bottles of 25-milligram chlorthalidone tablets after they failed dissolution testing, according to the FDA. Chlorthalidone is used for high blood pressure and fluid retention, according to the Mayo Clinic. That was a different medicine and a separate recall; the available information does not establish a connection between the two cases.
“failed dissolution specifications”
— U.S. Food and Drug Administration, as reported by Fox Business
Details on Test Results and Patient Effects
The reported information does not specify how the tablets failed, whether the issue affected all bottles in either lot, or whether any adverse events have been reported. It also does not give details about the investigation, the company’s explanation, or the steps taken to address the quality issue.
The report does not provide instructions for returning or replacing the medication, and it does not identify a contact number or say whether additional lots could be affected. Macleods Pharma USA had not provided comment to Fox Business at the time of its report. Readers should consult the FDA recall notice, their pharmacy or their prescriber for current instructions specific to their product.
Verify the Bottle Before Acting
Patients can check the lot number and NDC printed on their prescription bottle against the recalled identifiers. If both details match, they should promptly contact their pharmacist or prescriber for guidance on the appropriate next step, including whether a replacement is available. Because this is a prescription blood pressure medication, patients should not stop or alter treatment without professional guidance.
The recall remains ongoing in the information reported. Further details may come from Macleods Pharma USA or the FDA, including any updated instructions, investigation findings or information about the affected distribution. The available report does not state when the recall will be completed.
Key Questions
Which blood pressure medication was recalled?
The recall covers olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets made by Macleods Pharma USA, from lots 12251163A and 12251163B.
How can I tell if my bottle is affected?
Check the bottle for the lot number and NDC. The affected 30-count bottles have lot 12251163A and NDC 33342-246-07; the affected 90-count bottles have lot 12251163B and NDC 33342-246-10. Both lots expire May 31, 2027.
Why was the medication recalled?
The FDA listed the reason as failed dissolution specifications, meaning the tablets did not meet the required dissolution standard during testing. The report does not give further test details.
What does a Class II recall mean?
The FDA classification means use may cause temporary or medically reversible adverse health consequences; the likelihood of serious health consequences is considered remote, according to the report. It does not predict an individual patient’s outcome.
Should I stop taking the medication if my bottle matches?
Contact a pharmacist or prescriber promptly for advice about your specific prescription. Do not stop or change a blood pressure medication without professional guidance.
Source: foxbusiness.com
