Ascend Recalls Amlodipine and Olmesartan Medoxomil Tablets for Dissolution Issues
Ascend Laboratories is recalling 11,424 bottles of Amlodipine and Olmesartan Medoxomil tablets because they failed to meet dissolution specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II due to out-of-specification dissolution, which may cause temporary or medically reversible adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Ascend Laboratories, LLC is recalling 11,424 bottles of Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only. The product is manufactured by Alkem Laboratories Ltd., India, and distributed by Ascend Laboratories, LLC, Parsippany, NJ. The specific lot affected is # 25120696 with an expiration date of December 31, 2026.
The recall was initiated because the product is out of specification due to dissolution. This means the tablets may not break down and release the medication in the body as intended. The affected product was distributed nationwide within the United States.
Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
- Brand
- AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 11,424
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 (3)
- Lot # 25120696
- Exp Date: December 31
- 2026.
Distribution
Distributed nationwide across the United States.
Related recalls
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Similar recalls
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FDA (Drugs) · 2026-07-29
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