Clonidine Transdermal System 0.2 mg/day
Teva recalls Clonidine Transdermal System 0.2 mg/day over CGMP deviations from unapproved raw material.
Check your supply for the affected NDC 0591-3509-04 (carton) and NDC 0591-3509-54 (pouch). Stop using the product and contact Teva Pharmaceuticals for return and replacement instructions.
Why it was recalled
Teva Pharmaceuticals is recalling Clonidine Transdermal System, USP, 0.2 mg/day due to CGMP deviations involving the use of an unapproved raw material. The affected product is supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| 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 | 100060002, 100066802 | D-0473-2026 |
| 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 | 100060315, 100068644 | D-0472-2026 |
| 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 | 100053892, 100057899, 100062704 | D-0474-2026 |
Official source
Other recent recalls from Teva Pharmaceuticals USA, Inc
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification