Blood pressure medication recalled after failing dissolution test
Thousands of bottles of Olmesartan, Amlodipine and Hydrochlorothiazide tablets are being recalled in the US after the FDA found they failed quality standards.
Based on reporting by Sophia Compton (Fox Business) and Anna Loren (The Independent).
What happened
U.S. regulators have issued a nationwide recall of several lots of prescription blood‑pressure tablets after the pills failed a key quality test. The recall, announced by the Food and Drug Administration (FDA), involves three drugs commonly used to treat hypertension: Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide.
The affected products are manufactured by New Jersey‑based Macleods Pharma USA. The FDA says the pills did not meet dissolution specifications, meaning they did not dissolve properly during testing. The agency classified the recall as a Class II action, indicating that use of the medication could cause temporary or medically reversible adverse health effects, though serious consequences are considered unlikely.
Recall details
Lot 12251163A: 3,528 bottles containing 30 tablets each (NDC 33342‑246‑07)
Lot 12251163B: 216 bottles containing 90 tablets each (NDC 33342‑246‑10)
Expiration date on both lots: May 31 2027
Recall initiated by Macleods Pharma USA on Oct. 7; FDA classified it on Oct. 26
The recall affects products distributed across the United States and is still ongoing.
Why it matters
Blood‑pressure medications are taken daily by millions of Americans to manage hypertension, a leading risk factor for heart disease and stroke. A failure in the drug’s dissolution can reduce its effectiveness, potentially leaving patients with uncontrolled blood pressure. While the FDA notes that serious health outcomes are unlikely, the issue underscores the importance of rigorous quality control in pharmaceutical manufacturing.
Earlier this year, a separate recall involved chlorthalidone tablets from India‑based Inventia Healthcare Ltd., also due to failed dissolution testing. The recurrence highlights a broader challenge in ensuring consistency across global drug supply chains.
What it means for patients
If you have a prescription for Olmesartan, Amlodipine or Hydrochlorothiazide, take the following steps:
Locate the bottle and check the lot number and National Drug Code (NDC) printed on the label.
If the lot number matches 12251163A or 12251163B, or the NDC is 33342‑246‑07 (30‑count) or 33342‑246‑10 (90‑count), do not take the medication.
Contact your pharmacy or prescribing doctor immediately for a replacement or alternative treatment.
Return the recalled bottles to the pharmacy for proper disposal; many pharmacies accept returns for free.
Patients should continue to monitor their blood‑pressure readings and report any unusual symptoms to a healthcare professional.
How the recall was handled
The FDA’s recall classification system includes three levels. A Class II recall, like this one, signals that the product may cause temporary or reversible health issues, prompting manufacturers to act quickly but not indicating an immediate life‑threatening risk.
Macleods Pharma USA could not be reached for comment at the time of reporting. The agency’s public notice advises consumers to stay alert for any communications from their pharmacy or healthcare provider regarding the affected lots.
Background on the drugs
Olmesartan Medoxomil is an angiotensin II receptor blocker (ARB) that helps relax blood vessels. Amlodipine is a calcium‑channel blocker that widens arteries, and Hydrochlorothiazide is a thiazide diuretic that reduces fluid buildup. All three are often prescribed together in a single tablet to simplify treatment regimens.
In the United Kingdom, similar combinations are marketed under different brand names, but the active ingredients remain the same. American patients may recognize these drugs by their generic names, while UK patients might be more familiar with brand names like Benicar (Olmesartan) or Norvasc (Amlodipine).
What to watch next
The FDA will continue to monitor the recall’s progress and may issue updates if additional lots are identified. Patients and healthcare providers should stay tuned to FDA communications and pharmacy alerts for any further instructions.
For broader context, the FDA’s recall database provides a searchable list of all current drug recalls, which can be a useful resource for anyone wanting to verify the status of their medications.
