Unrated Drug recall · FDA · Published July 21, 2025

Recall: Ascend Amlodipine/Olmesartan Tablets Due to Dissolution Failure

Ascend Laboratories recalls specific lots of Amlodipine and Olmesartan Medoxomil tablets due to failed dissolution specifications. Check your bottle's lot number.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0576-2025Drug Ascend Laboratories ›

Recall notice

Failed Dissolution Specifications: low dissolution results

Take action

Contact the company

Recalling firmAscend Laboratories, LLC135 Us Highway 202 206 Ste 15 · Bedminster, NJ 07921-2608

✎ GovInfoNow plain-language explainer

Ascend Laboratories, LLC is recalling one lot of Amlodipine and Olmesartan Medoxomil Tablets (5 mg/40 mg) because they failed dissolution specifications, meaning the drug may not release properly into the body. The recall affects 8,568 bottles distributed nationwide in the USA. The record does not specify a remedy or what consumers should do with the product. Read more at govinfonow.com/recall/31960-recall-ascend-amlodipine-olmesartan-tablets-due-to-dissolution-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/31960-recall-ascend-amlodipine-olmesartan-tablets-due-to-dissolution-failure · Updated October 9, 2026 · FDA enforcement record: FDA #D-0576-2025

Cite this page

“Recall: Ascend Amlodipine/Olmesartan Tablets Due to Dissolution Failure.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/31960-recall-ascend-amlodipine-olmesartan-tablets-due-to-dissolution-failure. Based on FDA recall #D-0576-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0576-2025%22&limit=1).

The FDA announced on July 21, 2025, that Ascend Laboratories, LLC is recalling Amlodipine and Olmesartan Medoxomil Tablets due to failed dissolution specifications. The voluntary Class II recall affects 8,568 bottles distributed nationwide.

How to tell if you have it

Brand: Ascend Laboratories
Product: Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg
Packaging: 30-count bottle, Rx Only
Manufacturer: Alkem Laboratories Ltd., INDIA
Distributor: Ascend Laboratories, LLC, Parsippany, NJ 07054
NDC: 67877-501-30
Lot Code: 23121560
Expiration Date: 4/30/2026
Units Affected: 8,568 bottles

The hazard

The tablets have low dissolution results, meaning the drug may not dissolve properly. This failure of dissolution specifications is the primary hazard cited in the recall record.

Context

GovInfoNow's records show Ascend Laboratories, LLC has issued 35 other recalls since November 2, 2016. Recent brand recalls include Dabigatran Etexilate Capsules recalled on July 16, 2026, due to impurity risks and Amlodipine/Olmesartan tablets recalled on July 8, 2026, for low drug content. Other recent recalls of similar products include Teva Metoprolol Succinate Tablets Recall (January 29, 2026) and Inventia Healthcare Chlorthalidone Tablets Recall (June 5, 2026).

How to tell if you have this one

Check your bottle for NDC 67877-501-30, Lot number 23121560, and an expiration date of 4/30/2026. The product is a 30-count Rx-only bottle manufactured by Alkem Laboratories Ltd., India, and distributed by Ascend Laboratories, LLC in Parsippany, NJ.

Brand
Ascend Laboratories
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Bottle
Verify if your medication matches NDC 67877-501-30, Lot 23121560, Exp 4/30/2026.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine if you have the recalled product and what steps to take next.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 30 days after the firm started it.

Jul 21, 2025Firm started the recall
Aug 8, 2025FDA classified it Class II
Aug 20, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Ascend Laboratories recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/31960-recall-ascend-amlodipine-olmesartan-tablets-due-to-dissolution-failure">Recall: Ascend Amlodipine/Olmesartan Tablets Due to Dissolution Failure (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0576-2025 (July 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0576-2025 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.