Teva recalls Clonidine Transdermal System in 0.1, 0.2 and 0.3 mg/day strengths over unapproved raw material
The notice says these clonidine transdermal systems were made with an unapproved raw material, which it lists as a deviation from current good manufacturing practice.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- 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, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only…
- Hazard
- CGMP Deviations: use of an unapproved raw material
- Units
- 62,136 Cartons; 124,054 Cartons; 113,943 Cartons
- Where sold
- Within U.S
- FDA classification
- Class II · Ongoing
- Classified by FDA
- April 13, 2026
- Recall started
- March 19, 2026
- FDA enforcement report
- April 15, 2026
- Identifiers
- Codes: Lot: 100060002, Exp.: 07/2026; 100066802, Exp.: 05/2027
- FDA recall number: D-0473-2026
- Codes: Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027.
- FDA recall number: D-0472-2026
- Codes: Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
- FDA recall number: D-0474-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- 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, 0.1 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, 0.3 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
- Classification
- Class II (Ongoing)
- Distribution
- Within U.S
- Quantity
- 62,136 Cartons; 124,054 Cartons; 113,943 Cartons
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