Amlodipine and Olmesartan Medoxomil Recall 2026: What You Need to Know

The FDA has classified multiple recalls of this common blood pressure combination tablet after testing showed the olmesartan component fell below required levels. Here is what happened, which lots are affected, and what you should do if you take this medication.

What Is Being Recalled

Ascend Laboratories, LLC, based in New Jersey, has issued multiple recalls of amlodipine and olmesartan medoxomil combination tablets throughout 2025 and 2026. The tablets are manufactured by Alkem Laboratories Ltd. in India and distributed by Ascend in the United States. All of the recalls share the same root cause: the tablets failed dissolution testing, meaning the olmesartan medoxomil component fell below the specifications required for the drug to work as intended.

In practical terms, if you are taking an affected lot, your tablet may not be releasing the full dose of olmesartan into your bloodstream. That means your blood pressure may not be as well controlled as you and your doctor believe it to be, even though you are taking the medication as prescribed.

Affected Lots and Timeline

There have been three separate recalls of this medication from Ascend Laboratories over the past year. Here are the details for each:

July 2026 Recall (most recent) — 6,192 bottles of amlodipine and olmesartan medoxomil 10 mg/20 mg tablets, 30-count bottles. Lot number 25121311, expiration March 31, 2028. The recall was initiated July 8, 2026, and classified by the FDA on July 20, 2026.

May 2026 Recall — 15,696 bottles of amlodipine and olmesartan medoxomil 5 mg/40 mg tablets, 30-count bottles. Lot number 24123460, expiration October 31, 2027. Recall number D-0556-2026. Initiated by Ascend on May 5, 2026, and classified by the FDA on June 2, 2026.

July 2025 Recall — 8,568 bottles of amlodipine and olmesartan medoxomil 5 mg/40 mg tablets. Lot number 23121560, expiration April 30, 2026. Recall number D-0576-2025. Initiated July 21, 2025.

Across the three recall events, more than 30,000 bottles have been pulled from U.S. distribution. All three were classified as FDA Class II recalls, meaning the agency determined there is a possibility of "temporary or medically reversible adverse health consequences" with a low probability of serious harm.

NDC Numbers for Affected Products

The following National Drug Code (NDC) numbers are associated with the recalled products: 67877-499-30, 67877-499-90, 67877-500-30, 67877-500-90, 67877-501-30, 67877-501-90, 67877-502-30, and 67877-502-90. All are distributed by Ascend Laboratories. If your bottle has one of these NDC numbers, check the lot number against the recall list above.

What This Means for Your Health

The concern here is not that the tablets contain something harmful. The issue is that they may not contain enough of the active ingredient to do their job. Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) used to lower blood pressure. If the tablet is not dissolving properly, you may be getting a lower dose than what was prescribed, which could leave your blood pressure higher than expected.

High blood pressure that goes uncontrolled, even temporarily, increases the risk of heart attack, stroke, kidney damage, and other cardiovascular problems. This is why the FDA classifies these recalls as Class II — the problem is unlikely to cause immediate serious harm, but it is medically significant and needs to be addressed.

What You Should Do

If you take amlodipine and olmesartan medoxomil tablets, take these steps:

First, check your lot number. Look at the label on your medication bottle and compare it to the recalled lots listed above: 25121311, 24123460, or 23121560. Also note the NDC number on the label.

If your lot is affected, contact your pharmacist. Your pharmacist can provide a replacement supply from a different lot or a different manufacturer. Do not simply stop taking your medication — uncontrolled blood pressure is more dangerous than a lower-than-expected dose.

If your lot is not on the list, you can continue taking your medication as prescribed. These recalls apply only to the specific lots listed. Other lots and other manufacturers' versions of the same drug are not affected.

Let your doctor know. If you have been taking medication from a recalled lot, your doctor may want to check your blood pressure to confirm it has been adequately controlled. A simple office visit or home blood pressure reading can provide that reassurance.

Why This Keeps Happening

Three recalls of the same drug combination from the same distributor in roughly one year is notable. All three trace back to dissolution failures — the same type of quality control issue each time. Dissolution testing measures whether a tablet breaks down and releases its active ingredient on the expected timeline. When a tablet fails this test, it means the manufacturing process did not produce a consistent product.

Ascend Laboratories distributes a wide range of generic medications in the U.S. market. The tablets are manufactured by Alkem Laboratories in India. Repeated recalls for the same issue suggest a systemic manufacturing or quality control problem that has not been fully resolved. The FDA monitors these patterns and can take escalating enforcement action when a manufacturer shows a recurring quality problem.

How to Check for Drug Recalls

The FDA maintains a searchable database of all drug recalls and enforcement actions. You can check it anytime at FDA Safety Recalls. The agency also offers the openFDA API, a free public data service at api.fda.gov/drug/enforcement.json that provides structured recall data going back to 2004 and is updated weekly. You can search by drug name, manufacturer, recall classification, or date range.

RxGator will continue to monitor recall announcements and publish updates when they affect commonly prescribed medications. If you want to stay informed, bookmark our articles page and check back regularly.