FDAFDA · Food and drugs·Recall number D-0474-2026
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
Published April 15, 2026 · Recall initiated: March 19, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: use of an unapproved raw material
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CLONIDINE TRANSDERMAL SYSTEM
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Distributor
- Within U.S
- Lot
- Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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