300,000 Blood Pressure Patches Recalled — What Patients Taking Clonidine Need to Know

The short version: The FDA announced a recall of more than 300,000 cartons of clonidine transdermal patches — skin patches that deliver blood pressure medication — after discovering that an unapproved ingredient was used during manufacturing. The patches were made by Actavis Laboratories on behalf of Teva Pharmaceuticals. The recall was initiated March 19 and classified by the FDA on April 13, 2026. Teva says it conducted a health assessment and found no evidence that patients have been harmed.

What Is Clonidine and Who Uses These Patches

Clonidine is a medication most commonly prescribed to treat high blood pressure. It works by relaxing blood vessels so the heart doesn't have to work as hard to pump blood through the body. Keeping blood pressure under control reduces the risk of heart attacks, strokes, and kidney damage over time.

Doctors also prescribe clonidine for other conditions, including ADHD and anxiety, though these uses are not officially FDA-approved for clonidine specifically. Many patients prefer the patch form because it delivers medication steadily through the skin over seven days, avoiding the need to take a daily pill and reducing the ups and downs that can come with oral medication.

What Was Wrong With the Recalled Patches

Every ingredient in a prescription drug — including the materials used to make a patch itself — must be reviewed and approved by the FDA before it can be used. When a manufacturer uses a material that hasn't gone through that approval process, the FDA has no data to confirm whether it's safe over time.

In this case, Actavis used an unapproved raw material during manufacturing. The FDA describes the issue as a "lack of extractable and leachable data" for the unapproved material, meaning there's no testing data showing whether any part of that material could migrate into the medication or into a patient's body (Qz.com, 2026; FDA recall database, 2026).

Teva ran its own toxicological evaluation and concluded that the unapproved material posed no risk to patients. The FDA still required the recall as a precaution. This is a Class II recall, meaning the FDA considers serious consequences to be unlikely but not impossible.

Which Products Are Recalled

Three strengths of the Clonidine Transdermal System are included. Check the NDC number printed on your medication packaging against the list below:

• Clonidine Transdermal System, 0.1 mg/day — 124,054 cartons (NDC: 0591-3508-04)
• Clonidine Transdermal System, 0.2 mg/day — 62,136 cartons (NDC: 0591-3509-04)
• Clonidine Transdermal System, 0.3 mg/day — 113,943 cartons (NDC: 0591-3510-04)

Total recalled: approximately 300,133 cartons. The NDC number is a sequence of numbers separated by dashes printed on the drug label. If your packaging shows one of the three NDC numbers above, your patches are part of the recall.

What Patients Should Do

• Do NOT stop using your patches without talking to your doctor. Stopping blood pressure medication abruptly can cause a rapid spike in blood pressure, which is a medical emergency. Continuity of treatment is the priority.
• Call your pharmacist right away. They can check your specific lot against the recall, arrange a replacement, and help you stay covered without any gap in treatment.
• Check your packaging for the NDC numbers listed above. They're typically printed on both the outer carton and the individual patch pouches.
• If you have been using these patches and feel anything unusual — dizziness, unusual fatigue, chest discomfort, or changes in your blood pressure readings at home — let your doctor know and mention the recall.

Could There Be Lawsuits

When prescription drugs are manufactured with unapproved ingredients or materials that haven't been properly tested, patients who are harmed sometimes have legal options against the manufacturer. No lawsuits specifically tied to this clonidine patch recall have been publicly reported at this time, and Teva maintains no patients have been harmed.

If you believe you experienced a health problem connected to these recalled patches — particularly if you've had unusual blood pressure fluctuations or other health events — a free consultation with a lawyer can help you understand whether a case exists.