Amlodipine and olmesartan tablets recalled after failing dissolution specification testing
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, lot 23121560, are recalled nationwide for low dissolution results. The recall covers 8,568 bottles.
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 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a dissolution failure in a prescription medicine affects how the dose is released and no injuries are reported.
Plain-English summary
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg / 40 mg, in 30-count bottles, NDC 67877-501-30, are being recalled. The prescription-only product is manufactured by Alkem Laboratories Ltd. in India and distributed by Ascend Laboratories, LLC of Parsippany, New Jersey. The affected product is lot 23121560 with an expiry of 4/30/2026, and the recall covers 8,568 bottles distributed nationwide.
The recall was issued because the tablets failed dissolution specifications, returning low dissolution results. Dissolution testing measures how the tablet releases its active ingredients. The FDA classified the action as Class II.
Patients should check the lot number on their bottle against the recall and should not stop taking a prescribed blood pressure medicine without speaking to their pharmacist or prescriber about a replacement supply.
The recalled product
- Product
- AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
- Brand
- AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Cardiovascular
- Affected units
- 8,568
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.
Related recalls
Same brand · AMLODIPINE AND OLMESARTAN MEDOXOMIL
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FDA (Drugs) · 2026-07-29
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Similar recalls
- HighAscend amlodipine and olmesartan tablets failed dissolution specifications
FDA (Drugs) · 2026-06-10
- ModerateFDA Recalls Amlodipine and Olmesartan Tablets Over Failed Dissolution Test
FDA (Drugs) · 2026-07-29
- ModerateAmlodipine and Olmesartan Medoxomil Tablets Recalled for cGMP Deviations
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- LowAurobindo Recalls Amlodipine and Olmesartan Medoxomil Tablets Due to Discoloration
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