United StatesClonidine Transdermal System, USP 0.1 mg/day, 0.2 mg/day and 0.3 mg/day supplied in cartons of 4 systems and 4 adhesive covers (Rx only), manufactured by Actavis Laboratories UT and distributed by Actavis/Teva (NDCs 0591-3508-04/54, 0591-3509-04/54, 0591-3510-04/54) and specific lots (e.g., 100060315 exp. 04/2026; 100068644 exp. 01/2027; 100060002 exp. 07/2026; 100066802 exp. 05/2027; 100053892 exp. 04/2026; 100057899 exp. 05/2026; 100062704 exp. 02/2027) is being recalled in the U.S. by Teva Pharmaceuticals USA. The recall was initiated because of CGMP deviations involving the use of an unapproved raw material.
What's being recalled
Clonidine Transdermal System, USP, 0.1 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 0591-3508-04 carton, NDC 0591-3508-54 pouch
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
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 by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3510-04 carton, NDC 0591-3510-54 pouch
Recalling firm: Teva Pharmaceuticals USA, Inc, Parsippany, NJ, United States.
How to identify it
Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027. Lot: 100060002, Exp.: 07/2026; 100066802, Exp.: 05/2027 Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
The hazard
CGMP Deviations: use of an unapproved raw material
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Within U.S
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)