FDA-Drug2026-04-15Class IIPROCESSING DEFECT

Teva Clonidine Transdermal System 0.3 mg recalled for unapproved raw material

UNAPPROVED DRUGSNationwide distributionDrugs

What this means

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.
The agency's original wording
Hazard

CGMP Deviations: use of an unapproved raw material

Intended for
Adults
Illnesses reported
None reported
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-0474-2026

More Teva recalls

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