FDA recalls 300,000 cartons of Teva blood pressure patches over unapproved ingredient

The FDA has recalled about 300,133 cartons of clonidine transdermal skin patches sold under Teva Pharmaceuticals' label, citing the use of an unapproved raw material in the manufacturing process.

Actavis Laboratories manufactured the recalled products on behalf of Teva Pharmaceuticals, and they come in three dosage strengths: 0.1 mg/day, 0.2 mg/day, and 0.3 mg/day — all formulated as Clonidine Transdermal System, USP. Teva initiated the recall on March 19, 2026; the FDA assigned it a Class II classification on April 13, 2026, with affected lot expiration dates running from April 2026 into February 2027.

Under FDA definitions, a Class II recall applies when a product "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." Separately, introducing an unapproved ingredient into a drug's manufacturing process runs afoul of federal standards.

In a March 2026 alert, the California State Board of Pharmacy provided additional context on the safety question, explaining that because extractable and leachable data for the unapproved raw material had not been established, its safety profile in the finished product was unknown. That said, a toxicological evaluation and health hazard assessment Teva conducted found no adverse health consequences and determined that meaningful risk to patients was not applicable.

The three affected products, along with their National Drug Codes, are: Clonidine Transdermal System, USP, 0.1 mg/day (NDC: 0591-3508-04), accounting for 124,054 cartons; Clonidine Transdermal System, USP, 0.2 mg/day (NDC: 0591-3509-04), covering 62,136 cartons; and Clonidine Transdermal System, USP, 0.3 mg/day (NDC: 0591-3510-04), comprising 113,943 cartons. Part of the recall is being executed to the retail level, according to the California State Board of Pharmacy.

Among their approved uses, clonidine patches are a treatment option for high blood pressure; physicians also prescribe them outside their approved indications for conditions like ADHD and anxiety. Anyone currently using one of the affected lots should speak with their doctor before making any changes to their regimen, because stopping this medication without guidance can cause blood pressure to spike sharply.

Patients or healthcare providers who have questions or wish to report adverse reactions can contact the FDA's MedWatch program at 1-800-FDA-1088.