FDA Recalls Blood Pressure Medication Tablets for Dissolution Failure
Ascend Laboratories is recalling Amlodipine and Olmesartan Medoxomil tablets (5 mg/40 mg) due to failed dissolution specifications. The tablets may not dissolve properly, potentially reducing medication effectiveness.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. Although failed dissolution in a blood pressure medication poses a risk of reduced drug efficacy, the absence of documented illness or injury cases limits the severity to 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Ascend Laboratories, LLC is recalling Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg in 30-count bottles. This is a prescription medication used to treat high blood pressure. The affected lot (23121560, expiring 4/30/2026) was distributed nationwide.
The recall was initiated because the tablets failed to meet dissolution specifications. Low dissolution means the tablets may not break down properly in the body, potentially reducing the amount of active medication that reaches the bloodstream and compromising the drug's effectiveness.
The recall affects 8,568 bottles distributed nationwide. Patients taking medication from the affected lot should contact their healthcare provider or pharmacist for guidance. Do not stop taking blood pressure medication without consulting a healthcare professional, as discontinuation could pose health risks.
Patients and healthcare providers should verify whether their medication matches the recalled lot number (23121560, Exp 4/30/2026). Those with questions can contact Ascend Laboratories.
The recalled product
- Product
- AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
- Brand
- AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Antihypertensive
- Hazard
- dissolution-failure
- low-bioavailability
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 23121560
- Exp 4/30/2026
Distribution
Distributed nationwide across the United States.
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