FDAHealthMarch 19, 2026
Teva Pharmaceuticals USA, Inc — 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
⚠️ CGMP Deviations: use of an unapproved raw material
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- March 19, 2026
Within U.S
What's affected?
- 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
- Lot code
- 100053892
Additional details
Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 113,943 Cartons.
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