The Food and Drug Administration has updated the recall classification of certain blood pressure medicines sold in the United States were recalled last month.
On March 19, New Jersey-based Teva Pharmaceuticals USA, Inc. issued recalls for more than 300,000 cartons of Clonidine Transdermal System, according to FDA reports. The drugs, which treat blood pressure or hypertension, were recalled as they used an “unapproved raw material” and thus deviated from the agency’s regulations.
On April 13, the FDA categorized the recall under a “Class II” designation. According to the agency, the designation is only issued when the use of or exposure to a product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The product being recalled, Clonidine Transdermal System, is a non-invasive drug. It comes in the form of an adhesive skin patch, delivering a specific dose of medication into the bloodstream.
According to the first FDA report, 124,054 cartons of Clonidine Transdermal System, 0.1 mg/day, with lot numbers 100060315 and 100068644 and expiry dates of April 2026 and January 2027, respectively, are being recalled.
The second report cited the recall of 62,136 cartons of these adhesive medications, 0.2 mg/day, with lot numbers 100060002 and 100066802 and expiry dates of July 2026 and May 2027, respectively.
The third report announced the recall of 113,943 cartons of 0.3 mg/day Clonidine Transdermal System, with lot numbers 100053892, 100057899, and 100062704 and expiry dates of April 2026, May 2026, and February 2027, respectively.
In total, 300,133 cartons were recalled.
According to a document from the California State Board of Pharmacy, “the primary health concern associated with this recall is due to a lack of extractable and leachable data for the unapproved raw material to establish safety of the drug product.”
“Teva’s toxicological evaluation and health hazard assessment concluded that the severity of the hazard was assessed as no adverse health consequences and the overall risk of harm in the patient population is considered as not applicable.”
Each recalled carton contains four pouches of the product. The drugs were distributed under the Actavis Pharma Inc. label.
The Epoch Times reached out to Teva for comment but did not receive a response by publication time.
Customers whose medicines have been recalled should check their lot numbers to see if they match the numbers of the recalled drugs, the FDA advised in an October 2025 update.
“In some instances, stopping your medicine may be more harmful to your health than continuing to take the recalled medicine. Talk to your doctor or pharmacist if you have questions or concerns about your medicine,” the agency said.
In September last year, the FDA had warned Americans not to use unauthorized devices for measuring blood pressure.
Many blood pressure devices being sold over-the-counter do not have FDA marketing authorization, indicating that the agency has not conducted a safety evaluation of the devices.
“Inaccurate blood pressure measurements can lead to errors in diagnosing hypertension (high blood pressure) or hypotension (low blood pressure), which may result in delayed treatment or lack of treatment. This can lead to patient harms, such as stroke, heart attack, heart failure, kidney failure, cognitive decline, and early death,” the agency warned.
“Because high blood pressure often has no physical symptoms, accurate measurements are critical to preventing serious complications.”