28,000+ Bottles of Blood Pressure Drug Recalled Nationwide

More than 28,000 bottles of the prescription blood pressure medication ramipril have been recalled across the United States after testing identified a quality issue involving an impurity in the drug.

The U.S. Food and Drug Administration (FDA) classified the recall as a Class II recall on Sept. 3, 2026, according to the agency's enforcement report. The manufacturer, Hikma Pharmaceuticals USA Inc., had voluntarily initiated the recall on Aug. 24.

The recall involves specific lots of 10-milligram ramipril capsules. Patients who take ramipril are being advised to check their prescription bottles and speak with a pharmacist or health care professional if they believe their medication may be affected.

What Ramipril Products Are Included in the Recall?

The recall applies specifically to 10-milligram ramipril capsules sold in two bottle sizes.

The affected products include:

• 100-capsule bottles: NDC 76282-673-01
• 500-capsule bottles: NDC 76282-673-05

According to the FDA information cited in the recall notice, 25,970 bottles of the 100-capsule product and 2,384 bottles of the 500-capsule product are affected. Together, the two package sizes account for 28,354 bottles distributed nationwide.

Two lots are included in the recall:

• Lot AC5470A
• Lot AC5470B

Both lots have an expiration date of July 2027.

The capsules were manufactured by West-Ward Columbus Inc. in Columbus, Ohio, for Exelan Pharmaceuticals Inc., based in Boca Raton, Florida.

The FDA's enforcement information indicated that the recall was still ongoing as of its latest update, with no termination date listed.

Why Was Ramipril Recalled?

The FDA said the products failed certain impurity and degradation specifications during testing.

More specifically, the issue involved an out-of-specification result for dicyclohexylurea, commonly abbreviated as DCU. DCU is described in the FDA recall information as a process impurity associated with the manufacturing process.

A failed specification does not necessarily mean that every bottle containing the medication is unsafe or that every patient taking it will experience a health problem. However, pharmaceutical manufacturers are required to meet established quality standards, and products that do not meet those specifications can be subject to regulatory action and recall.

The recall therefore serves as a precautionary measure to remove the affected lots from the supply chain.

Ramipril is a generic medication. It is also the generic form of the brand-name drug Altace. The recall described here concerns the specified ramipril products and lots, not Altace generally.

What Is Ramipril Used For?

Ramipril belongs to a group of medications known as angiotensin-converting enzyme, or ACE, inhibitors.

ACE inhibitors work by helping blood vessels relax. This can reduce blood pressure and make it easier for the heart to pump blood.

Doctors commonly prescribe ramipril to treat high blood pressure, also known as hypertension. Depending on a patient's medical circumstances, it may also be used for certain heart-related conditions, including heart failure following a heart attack.

Medications such as ramipril can play an important role in controlling cardiovascular risk. High blood pressure can place long-term strain on the heart and blood vessels and can contribute to serious complications involving the heart, brain and kidneys.

Because of this, patients who take ramipril should not assume that they should simply stop taking their medication because they have heard about the recall.

Instead, they should first determine whether their specific prescription is part of the recalled lots and discuss the appropriate next step with a qualified health professional.

What Does an FDA Class II Recall Mean?

The FDA uses different classifications to communicate the potential level of risk associated with a recalled product.

A Class II recall generally means that use of, or exposure to, the affected product could cause temporary or medically reversible health consequences, or that the probability of serious adverse health consequences is considered remote.

The classification does not mean that every person who used the recalled medication will become sick.

It also does not mean that all ramipril products are being recalled.

The recall is limited to the specific product information and lots identified by the manufacturer and FDA.

What Should Patients Taking Ramipril Do?

Patients who currently take 10-milligram ramipril can start by examining the label on their prescription bottle.

Look for the medication name, strength, NDC number and lot information. If the bottle matches the recalled product and lot numbers, contact a pharmacist or health care professional for guidance.

Patients should not stop taking blood pressure medication on their own without speaking with a medical professional. Suddenly discontinuing a prescribed medication can have consequences, particularly for people who rely on it to control high blood pressure or manage a cardiovascular condition.

A pharmacist can help determine whether a patient's prescription came from an affected lot and explain whether a replacement product is available.

Patients who no longer have the original prescription bottle can also contact the pharmacy that filled the prescription for assistance.

Ramipril Recall Is Part of a Broader Pattern of Medication Recalls

The ramipril recall is one of several blood pressure medication recalls reported during 2026 involving manufacturing or quality-control concerns.

In August, Novartis Pharmaceuticals Corporation recalled certain bottles of Diovan, a blood pressure medication containing valsartan, after the affected product failed dissolution specifications. Dissolution testing helps determine whether a tablet releases its active ingredient at the required rate.

That recall involved a specific lot of 160-milligram tablets and was also classified as a Class II recall.

Earlier in the year, Inventia Healthcare Limited recalled more than 11,000 bottles of chlorthalidone tablets after a dissolution specification failure was identified.

In March, Appco Pharma LLC recalled more than 175,000 bottles of prazosin hydrochloride capsules after testing identified elevated levels of a nitrosamine impurity. Certain nitrosamines can be a long-term health concern when exposure exceeds established safety limits.

These recalls highlight why pharmaceutical quality-control systems are important. Manufacturing problems can involve a range of issues, including impurities, dissolution problems, labeling errors, contamination or other failures to meet established specifications.

Where Can Consumers Find Official Recall Information?

Consumers and health care professionals should rely on official sources when checking whether a medication has been recalled.

The FDA's enforcement report provides information about the ramipril recall, including the affected product, lot numbers, package sizes and recall classification.

The Bottom Line

More than 28,000 bottles of specific 10-milligram ramipril products have been recalled nationwide after the affected lots failed specifications involving the process impurity dicyclohexylurea.

The recall involves lots AC5470A and AC5470B, both with a July 2027 expiration date. The affected bottles were sold in 100-capsule and 500-capsule sizes.

The FDA has classified the action as a Class II recall, indicating that the potential health consequences are considered temporary or medically reversible, or that serious harm is considered unlikely.

For patients, the most important step is to check whether their particular prescription matches the recalled product and lot information. Anyone who believes they have an affected product should contact a pharmacist or health care professional for individualized guidance rather than stopping treatment without medical advice.

Source: U.S. Food and Drug Administration, Enforcement Report, Event 99711.

Medical Disclaimer

This article is provided for general informational and educational purposes only. It is not medical advice, diagnosis or treatment, and it should not be used as a substitute for advice from a qualified doctor, pharmacist or other health care professional. Medication recalls and FDA information can change, so readers should verify current information through official FDA resources and their health care providers. Do not stop, change or replace a prescribed medication without first consulting an appropriate medical professional.