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Drug FDA Class II Ongoing cGMP deviation

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

Teva Pharmaceuticals USA, Inc Published Apr 15, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 50/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Teva Pharmaceuticals USA, Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP Deviations: use of an unapproved raw material

Hazards

Unapproved Raw Material · primary

Affected products (1)

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

CLONIDINE TRANSDERMAL SYSTEM · 124,054 Cartons

NDC: 0591-3508, 0591-3509, 0591-3510, 0591-3508-54, 0591-3508-04, 0591-3509-54, 0591-3509-04, 0591-3510-54, 0591-3510-04
Lot codes: 100060315
Code info: Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027.

Affected areas

Within U.S

Timeline

  1. Initiated
    Mar 19, 2026
  2. Published
    Apr 15, 2026
Recall number
D-0472-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.