Teva Clonidine Patch Recall, 113,943 Cartons, Unapproved Material
FDA Drug Recalls (Class II)
Summary
FDA classified a Class II recall for Teva Clonidine Transdermal System (0.3 mg/day) due to CGMP deviations involving use of an unapproved raw material. The recall affects 113,943 cartons across three lots (100053892, 100057899, 100062704), distributed within the US. The voluntary firm-initiated recall began on March 19, 2026 and was classified by FDA on April 13, 2026.
What changed
FDA classified a Class II recall for Teva Clonidine Transdermal System due to CGMP deviations involving use of an unapproved raw material. The recall affects 113,943 cartons across three lots distributed within the US. Healthcare providers and patients using Clonidine Transdermal System should verify their inventory against affected lot numbers (100053892, 100057899, 100062704). Any matching product should be quarantined and returned per standard recall procedures.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Teva Pharmaceuticals USA, Inc
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0474-2026 · 20260415 · Ongoing · Voluntary: Firm initiated
Product
Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed ...
Reason for Recall
CGMP Deviations: use of an unapproved raw material
Affected Lot Numbers / Codes
Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
Quantity
113,943 Cartons
Firm Notification Method
Letter
Distribution
Within U.S
Initiated
20260319
FDA Classified
20260413
Product Registration
Brand: CLONIDINE TRANSDERMAL SYSTEM
Generic: CLONIDINE
Manufacturer: Actavis Pharma, Inc.
Application: ANDA090873
NDC: 0591-3508, 0591-3509, 0591-3510
Drug Label Context (from openFDA)
The following is from the manufacturer's FDA-approved drug label, not recall-specific. Provided for context.
Indications & Usage
INDICATIONS AND USAGE Clonidine transdermal system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.
Dosage & Administration
DOSAGE AND ADMINISTRATION Apply clonidine transdermal system once every 7 days to a hairless area of intact skin on the upper outer arm or chest. Each new application of clonidine transdermal system should be on a different skin site from the previous location. If the system loosens during 7-day wearing, the adhesive cover should be applied directly over the system to ensure good adhesion. There have been rare reports of the need for patch changes prior to 7 days to maintain blood pressure control. To initiate therapy, clonidine transdermal system dosage should be titrated according to indi...
Contraindications
CONTRAINDICATIONS Clonidine transdermal system should not be used in patients with known hypersensitivity to clonidine or to any other component of the system.
Warnings
WARNINGS Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, tremor, and confusion accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of highe...
Adverse Reactions
ADVERSE REACTIONS Clinical t rial e xperience w ith Clonidine Transdermal System Most systemic adverse effects during clonidine transdermal system therapy have been mild and have tended to diminish with continued therapy. In a 3-month multi-clinic trial of clonidine transdermal system in 101 hypertensive patients, the systemic adverse reactions were, dry mouth (25 patients) and drowsiness (12), fatigue (6), headache (5), lethargy and sedation (3 each), insomnia, dizziness, impotence/sexual dy...
Drug Interactions
Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated. Monitor heart rate i...
How Supplied
HOW SUPPLIED Clonidine transdermal systems USP, 0.1 mg per day for one week, 0.2 mg per day for one week, and 0.3 mg per day for one week are supplied as 4 pouched systems and 4 adhesive covers per carton. Each system contains 1.97 mg, 3.94 mg, or 5.90 mg clonidine. See chart below. Programmed Delivery Clonidine in vivo Per Day Over 1 Week Clonidine Content Size Code Clonidine Transdermal Syste...
Storage & Handling
STORAGE AND HANDLING Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Manufactured by: Actavis Laboratories UT, Inc. Salt Lake City, UT 84108 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Address medical inquiries to Actavis at 1-888-838-2872. Rev. B 1...
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