FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Teva Clonidine Transdermal System 0.3 mg recalled for unapproved raw material
UNAPPROVED DRUGSNationwide distribution
Stop using recalled Teva Clonidine patches
Teva Pharmaceuticals is recalling specific batches of Clonidine Transdermal System patches (0.3 mg/day) because they were manufactured using an unapproved raw material that does not meet quality standards. The affected patches were distributed in the U.S. No injuries have been reported.
- Check if your Clonidine patch matches one of these lot numbers: 100053892 (exp. 04/2026), 100057899 (exp. 05/2026), or 100062704 (exp. 02/2027).
- If you have a recalled patch, contact your pharmacy or doctor before stopping your medication.
- Return the recalled patches to your pharmacy.
Hazard
CGMP Deviations: use of an unapproved raw material
Sold states
Within U.S
Affected count
113,943 Cartons
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0474-2026More Teva Pharmaceuticals USA, Inc recalls
- FDA-Drug2026-04-29Teva Claravis (isotretinoin) 10 mg recalled for elevated tretinoin impurity levels
- FDA-Drug2026-04-15Teva Clonidine Transdermal System 0.2 mg/day recalled for unapproved raw material
- FDA-Drug2026-04-15Teva Clonidine Transdermal System 0.1 mg recalled for unapproved raw material
- FDA-Drug2026-04-15Teva Isotretinoin 40 mg capsules recalled for inconsistent strength
- FDA-Drug2026-04-15Teva Isotretinoin 30 mg capsules recalled for potency inconsistency
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