FDA-Drug2026-04-15Class IICHEMICAL

Teva Clonidine Transdermal System 0.1 mg recalled for unapproved raw material

UNAPPROVED DRUGSNationwide distribution

Stop using recalled Teva Clonidine patches

Teva Pharmaceuticals is recalling certain Clonidine Transdermal System patches (0.1 mg/day) because they were manufactured using an unapproved raw material that does not meet FDA standards. The affected patches were distributed in the U.S. The company and FDA are working to ensure the product is removed from use.

  • Check if your Clonidine patch is from lot 100060315 (expires 04/2026) or lot 100068644 (expires 01/2027)
  • Do not stop taking your medication without talking to your doctor
  • Contact your pharmacy or doctor immediately if you have one of the affected patches
  • Your doctor can provide an alternative blood pressure medication or a replacement supply
Hazard

CGMP Deviations: use of an unapproved raw material

Sold states
Within U.S
Affected count
124,054 Cartons
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
Clonidine Transdermal System, USP, 0.1 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 0591-3508-04 carton, NDC 0591-3508-54 pouch

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0472-2026

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