Drug recall D-0474-2026
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 by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3510-04 carton, NDC 0591-3510-54 pouch
Reason for recall
CGMP Deviations: use of an unapproved raw material
Lots and codes
Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Quantity
- 113,943 Cartons
- Distribution
- Within U.S
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 19, 2026
Related products
- Clonidine transdermal system – drug information
- NDC 0591-3509 Clonidine transdermal system · Clonidine .2 mg/d · Actavis Pharma, Inc.
- NDC 0591-3510 Clonidine transdermal system · Clonidine .3 mg/d · Actavis Pharma, Inc.
- NDC 0591-3508 Clonidine transdermal system · Clonidine .1 mg/d · Actavis Pharma, Inc.