FDA Recalls Amlodipine and Olmesartan Tablets Over Failed Dissolution Test
Ascend Laboratories is recalling 6,192 bottles of Amlodipine and Olmesartan Medoxomil tablets nationwide due to failed dissolution specifications and Olmesartan content below specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The rubric assigns score 2 (Moderate) to FDA Class II recalls without reported hospitalization or injury, as the hazard is a quality specification failure rather than a confirmed safety issue.
Plain-English summary
Ascend Laboratories, LLC is recalling Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 tablets per bottle, NDC 67877-500-30. The recall covers 6,192 bottles distributed nationwide in the USA.
The recall is being issued because the product failed dissolution specifications and the Olmesartan Medoxomil content was found to be below established specifications. The affected product is identified by Lot 25121311 with an expiry date of 3/31/2028.
This is a Class II recall, meaning the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should immediately check existing inventory for the affected lot. Any unused product should be returned to the point of purchase. Questions may be directed to Ascend Laboratories, LLC.
The recalled product
- Product
- AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
- Brand
- AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Manufacturer
- Ascend Laboratories, LLC
- Hazard
- failed-quality-test
- content-below-spec
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 25121311
- expiry 3/31/2028
Distribution
Distributed nationwide across the United States.
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