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-0472-2026More 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 0.3 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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