Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories
Summary
The FDA issued a Class II for Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx On by Ascend Laboratories, LLC. Reason: Failed Dissolution Specifications: low dissolution results.
Details
Source
Drug Recall
External ID
D-0576-2025
Action Date
2025-08-20
Status
Ongoing
Category
drug
Product Description
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
Lot/Code Info: Lot 23121560, Exp 4/30/2026
Quantity Affected: 8,568 bottles
Reason for Recall
Failed Dissolution Specifications: low dissolution results
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-21
Company
Bedminster, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Ascend Laboratories, LLC has 30 FDA actions in our database, including 30 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ascend Laboratories, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ascend Laboratories, LLC have FDA actions?
Ascend Laboratories, LLC has 30 FDA actions in our database, including 30 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0576-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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