More Than 28,000 Bottles of Ramipril Recalled Nationwide

Consumers who take ramipril should check their prescription information after a nationwide recall involving two lots of the 10-milligram medication.

Hikma Pharmaceuticals USA initiated the voluntary recall on August 24, 2026. The FDA has classified it as a Class II recall, and the recall remains ongoing.

What Is Being Recalled?

The recall is limited to certain Ramipril Capsules USP, 10 mg, manufactured by West-Ward Columbus Inc. for Exelan Pharmaceuticals.

Affected products are:

100-count bottlesNDC: 76282-673-01Lot: AC5470AExpiration: July 2027

500-count bottlesNDC: 76282-673-05Lot: AC5470BExpiration: July 2027

Approximately 28,354 bottles are included: 25,970 bottles containing 100 capsules and 2,384 bottles containing 500 capsules.

That number represents bottles distributed, not the number of patients affected. Large medication bottles may be used within the pharmacy distribution system to fill individual prescriptions.

Why Was Ramipril Recalled?

According to FDA enforcement information, testing produced an out-of-specification result for a manufacturing impurity called dicyclohexylurea, or DCU.

The available FDA recall information does not establish that patients taking these lots have suffered a specific illness from the impurity. For that reason, Maria Approved It is not characterizing the recall as causing cancer, poisoning, or another specific condition without evidence supporting such a claim.

FDA classified the action as Class II. That classification is used when exposure to a recalled product may cause temporary or medically reversible health effects, or when the probability of serious health consequences is considered remote.

Does This Mean All Ramipril Is Recalled?

No.

The current recall applies to the specific 10-mg Exelan product, NDC numbers and lots listed above. Other strengths, manufacturers and lots of ramipril should not automatically be considered recalled.

The affected Exelan 10-mg capsules are described in federal drug-label information as blue opaque capsules marked “54 602.” Consumers should still verify the NDC and lot information rather than relying on the capsule's appearance alone.

What Should Patients Do?

If you take ramipril, check your prescription label and contact your pharmacy if you cannot determine the manufacturer or lot.

If your medication matches the recalled product, contact your pharmacist or prescribing healthcare professional for instructions.

Do not abruptly discontinue a prescribed medication solely because you saw a recall notice. FDA guidance states that patients can generally continue using medications involved in Class II recalls unless FDA or the recalling company provides different instructions. In some circumstances, stopping a medicine may create a greater health risk than continuing it while a replacement is arranged.

FDA Recall Number: D-0831-2026Recall status: OngoingDistribution: Nationwide United States

Maria Approved It Bottom Line

This recall deserves attention, but the headline needs context. It concerns specific lots of one 10-mg ramipril product, not every ramipril prescription in the country.

Check the numbers. Contact the pharmacy. Don't panic, and don't discontinue a prescription medication without appropriate guidance.