Actavis Clonidine Transdermal System
Clonidine Transdermal System was made with an unapproved raw material.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
2 photos
What happened
Teva Pharmaceuticals USA, Inc., of Parsippany, New Jersey, recalled Clonidine Transdermal System, USP, in 0.1 mg/day, 0.2 mg/day, and 0.3 mg/day strengths, because of CGMP Deviations: use of an unapproved raw material. The recall began March 19, 2026, and was added to the FDA's Enforcement Report on April 13, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
Clonidine Transdermal System, USP
- Strength
- 0.2 mg
- UPC
- 100060002
- 100066802
- Strength
- 0.1 mg
- UPC
- 100060315
- 100068644
- Strength
- 0.3 mg
- UPC
- 100053892
- 100057899
- 100062704
From the FDA notice
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
Details
- Company began the recall
- Sold in
Within U.S
- Event ID
- 98614
- Recall numbers
- D-0472-2026 to D-0474-2026
- Company
- Teva Pharmaceuticals USA, IncParsippany, New Jersey
- Hazard
- Manufacturing deviation
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
