FDA-Drug2026-04-15Class II
Clonidine Transdermal System, USP, 0.2 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 by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch
Teva Pharmaceuticals USA, Inc
Hazard
CGMP Deviations: use of an unapproved raw material
Sold states
Within U.S
Affected count
62,136 Cartons
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
Clonidine Transdermal System, USP, 0.2 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 by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0473-2026Original summary
Clonidine Transdermal System, USP, 0.2 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 by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch CGMP Deviations: use of an unapproved raw material Lot: 100060002, Exp.: 07/2026; 100066802, Exp.: 05/2027 Distribution: Within U.S Affected quantity: 62,136 Cartons
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