Teva Pharmaceuticals recalled 124,054 cartons of Clonidine Transdermal System due to CGMP deviations from an unapproved raw material. The recall affects products sold in the United States. Consumers should stop using the product immediately and consult a healthcare provider for guidance.
CGMP Deviations: use of an unapproved raw material
Consumers and healthcare providers should stop using this product immediately. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. Notification method: Letter
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Clonidine transdermal systems deliver a controlled amount of clonidine for hypertension management. They are prescribed and distributed to pharmacies and clinics.
CGMP deviations indicate use of an unapproved raw material, which could lead to quality or safety concerns.
This recall is not necessarily part of a broader pattern but highlights CGMP deviations in drug manufacturing.
Direct impact on patients and clinics; potential disruption of therapy and need for immediate cessation and medical guidance.
Recall notification letter and FDA enforcement page D-0472-2026.
Refunds or replacements described in recall letters; typically several weeks.
Keep recall notice, lot numbers, NDCs, expiration dates, and correspondence with suppliers.
Brand: CLONIDINE TRANSDERMAL SYSTEM. Manufacturer: Actavis Laboratories UT Inc., Salt Lake City, UT 84108. Distributor: Teva Pharmaceuticals USA, Inc. NDC 0591-3508-04 carton, NDC 0591-3508-54 pouch. Quantity: 124,054 cartons. Status: Active recall as of 2026-03-19. Distribution: Within the U.S.
No specific injuries or incidents are listed in the provided data.
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Teva-affiliated Clonidine Transdermal System recalls 113,943 cartons after CGMP deviations. Unapproved raw material prompts recall. Stop use immediately and contact Teva or a healthcare provider for guidance.
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