The U.S. Food and Drug Administration (FDA) has classified a nationwide recall of nearly 3,800 bottles of prescription blood pressure medication manufactured by Macleods Pharma USA, Inc.
The recall involves 3,744 bottles of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets, a generic combination medication used to treat high blood pressure.
The recall was initiated October 7, 2026, after the medication failed dissolution specifications during testing. This means the pills may not dissolve properly, potentially affecting how the medication is absorbed and its effectiveness.
On October 26, the FDA classified the recall as Class II. This classification indicates that use of the affected medication could cause temporary or medically reversible health consequences, although the likelihood of serious health problems is considered remote.
Identifying the Recalled Medication
The recall affects the following products:
- Medication: Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets, 40 mg/10 mg/12.5 mg
- Manufacturer: Macleods Pharma USA, Inc.
30-count bottles:
- NDC: 33342-246-07
- Lot number: 12251163A
- Expiration date: May 31, 2027
- Quantity recalled: 3,528 bottles
90-count bottles:
- NDC: 33342-246-10
- Lot number: 12251163B
- Expiration date: May 31, 2027
- Quantity recalled: 216 bottles
The affected medication was distributed nationwide.
What Consumers Should Do
Consumers should check their prescription bottles for the medication name, National Drug Code (NDC) and lot number to determine whether their prescription is included in the recall.
Anyone who believes they have an affected bottle should contact their pharmacist or healthcare provider for guidance on obtaining a replacement and determining the appropriate next steps.
Patients should not stop taking prescribed blood pressure medication without first consulting their healthcare provider.
The recall was initiated voluntarily by Macleods Pharma USA, Inc. and remains classified as Class II by the FDA.