A pill has a surprisingly simple first task. Before it can do anything for your blood pressure, it has to break down in your body at the expected pace. Some tablets from two batches of a common three-in-one medication didn't pass that test, and now they're being recalled across the United States.
What's being recalled
The drug is a combination tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide, made for Macleods Pharma USA, a company based in New Jersey. The recall covers 3,528 bottles of 30 tablets from lot 12251163A, and 216 bottles of 90 tablets from lot 12251163B. That makes 3,744 bottles in total, all with an expiry date of 31 May 2027, and they were distributed nationwide.
The company started the recall itself on 7 October. On 26 October, the US Food and Drug Administration classified it as Class II, its middle category, used when a product could cause temporary or medically reversible health problems and the chance of serious harm is considered remote.
What “failed dissolution” means
The FDA's listed reason is “failed dissolution specifications”. In plain language: in a lab test, the tablets didn't dissolve the way the specification requires. That matters because how fast a tablet dissolves affects how much medicine reaches your body, and when.
It isn't the only recent case. In September, India-based Inventia Healthcare recalled 13,567 bottles of 25-milligram chlorthalidone tablets, another blood pressure drug, after the same kind of test failure.
What to do if you take this medicine
Don't stop on your own. Blood pressure medicine works best when it's taken steadily, and a sudden gap may do more harm than the recall itself.
- Look on your bottle or packaging for the lot number and the National Drug Code.
- If your pharmacy moved the pills into its own bottle, call and ask which lot you were given.
- If you have an affected lot, ask your pharmacist or doctor for a replacement.
If your bottle has a different lot number, this recall doesn't touch it, and your pills can carry on with their one job.