FDA-Drug2026-04-15Class IICHEMICAL
Teva Clonidine Transdermal System 0.2 mg/day recalled for unapproved raw material
UNAPPROVED DRUGSNationwide distribution
Check your Clonidine patch lot numbers
Teva Pharmaceuticals is recalling specific lots of Clonidine Transdermal System (0.2 mg/day) patches because they were made with an unapproved raw material that does not meet manufacturing standards. Two lots are affected: 100060002 (expires 07/2026) and 100066802 (expires 05/2027). No injuries have been reported.
- Check if your Clonidine patch matches lot 100060002 or 100066802
- If it does, contact your pharmacy or doctor before stopping the medication
- Do not suddenly stop using Clonidine without medical guidance, as this can cause serious blood pressure changes
- Ask your pharmacist for a replacement from a non-recalled lot
Hazard
CGMP Deviations: use of an unapproved raw material
Sold states
Within U.S
Affected count
62,136 Cartons
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0473-2026More 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 0.1 mg recalled for unapproved raw material
- FDA-Drug2026-04-15Teva Clonidine Transdermal System 0.3 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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