Taking blood pressure medication is not out of the ordinary, as national data suggest nearly one in every two American adults do. While many blood pressure medications are administered by mouth, a newly published U.S. Food and Drug Administration (FDA) report highlights a less conventional delivery method for blood pressure management: a transdermal skin patch.
In three alerts shared April 13, the FDA has announced recalls on what appears to be a total of 300,133 cartons of Clonidine transdermal patches due to what the report calls “the use of an unapproved raw material” in the manufacturing process.
Elaborating further, in March 2026 the California State Board of Pharmacy noted:
“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.”
That notice also specified that part of the recall was being executed “to the retail level.”
The report reveals that the recall was initiated on March 19, 2026, then further classified as Class II by the FDA on April 13, 2026. This means use of the products “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” The use of an unapproved ingredient is a violation of federal manufacturing standards.
The affected products, made by Actavis Laboratories for Teva Pharmaceuticals, are three separate dosages in milligrams (mg):
Clonidine Transdermal System, USP, 0.1 mg/day (National Drug Code or “NDC”: 0591-3508-04) – 124,054 cartons
Lots: 100060315, Exp. 04/2026; 100068644, Exp. 01/2027
Clonidine Transdermal System, USP, 0.2 mg/day (NDC: 0591-3509-04) – 62,136 cartons
Lots: 100060002, Exp. 07/2026; 100066802, Exp. 05/2027
Clonidine Transdermal System, USP, 0.3 mg/day (NDC: 0591-3510-04) – 113,943 cartons
Lots: 100053892, Exp. 04/2026; 100057899, Exp. 05/2026; 100062704, Exp. 02/2027
Clonidine patches are commonly prescribed to treat high blood pressure, and are also used off-label for conditions including ADHD and anxiety.
If you use any of these patches, it’s not advisable to stop usage without first speaking to your doctor. Abruptly discontinuing the drug has the potential to trigger a rebound spike in blood pressure.
If you have one of the affected lots, contact your pharmacist or prescribing physician about next steps. Healthcare providers and patients can report adverse reactions to the FDA’s MedWatch program at 1-800-FDA-1088.
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