{"id":400150,"date":"2026-04-15T18:03:09","date_gmt":"2026-04-15T18:03:09","guid":{"rendered":"https:\/\/www.newsbeep.com\/ie\/400150\/"},"modified":"2026-04-15T18:03:09","modified_gmt":"2026-04-15T18:03:09","slug":"300000-cartons-of-blood-pressure-medicine-recalled-nationwide-for-unapproved-formulation","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ie\/400150\/","title":{"rendered":"300,000 Cartons of Blood Pressure Medicine Recalled Nationwide for ‘Unapproved’ Formulation"},"content":{"rendered":"

Taking blood pressure medication is not out of the ordinary, as national data<\/a> suggest nearly one in every two American adults do. While many blood pressure medications<\/a> 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.<\/p>\n

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 \u201cthe use of an unapproved raw material\u201d in the manufacturing process.<\/p>\n

Elaborating further, in March 2026 the California State Board of Pharmacy<\/a> noted:<\/p>\n

\u201cThe 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\u2019s 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.\u201d<\/p>\n

That notice also specified that part of the recall was being executed \u201cto the retail level.\u201d<\/p>\n

The report reveals that the recall was initiated on March 19, 2026, then further classified as Class II<\/a> by the FDA on April 13, 2026. This means use of the products \u201cmay cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.\u201d The use of an unapproved ingredient is a violation of federal manufacturing standards.<\/p>\n

The affected products, made by Actavis Laboratories for Teva Pharmaceuticals, are three separate dosages in milligrams (mg):<\/p>\n

Clonidine Transdermal System, USP, 0.1 mg\/day<\/a> (National Drug Code or \u201cNDC\u201d: 0591-3508-04) \u2013 124,054 cartons<\/p>\n

Lots: 100060315, Exp. 04\/2026; 100068644, Exp. 01\/2027<\/p>\n

Clonidine Transdermal System, USP, 0.2 mg\/day<\/a> (NDC: 0591-3509-04) \u2013 62,136 cartons<\/p>\n

Lots: 100060002, Exp. 07\/2026; 100066802, Exp. 05\/2027<\/p>\n

Clonidine Transdermal System, USP, 0.3 mg\/day<\/a> (NDC: 0591-3510-04) \u2013 113,943 cartons<\/p>\n

Lots: 100053892, Exp. 04\/2026; 100057899, Exp. 05\/2026; 100062704, Exp. 02\/2027<\/p>\n

Clonidine patches are commonly prescribed to treat high blood pressure, and are also used off-label for conditions including ADHD and anxiety.<\/p>\n

If you use any of these patches, it\u2019s 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.<\/p>\n

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\u2019s MedWatch program<\/a> at 1-800-FDA-1088.<\/p>\n

For daily wellness updates, subscribe to The Healthy newsletter<\/a> and follow The Healthy on Facebook<\/a> and Instagram<\/a>. Keep reading:<\/p>\n

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