Clonidine Transdermal System Patch
FDA Recall NDC 0591-3510
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Clonidine Transdermal System (NDC 0591-3510). A significant event, classified as Class II, was initiated on Mar 19, 2026 by Actavis Pharma, Inc.. The reported reason for this action was: "CGMP Deviations: use of an unapproved raw material"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations: use of an unapproved raw material
Mar 19, 2026
Apr 15, 2026
124,054 Cartons
Recall Profile & Regulatory Data
Event ID
98614
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Within U.S
Product Description
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
Batch or Lot Expiration Information
Lot# Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027.
Affected Packages Involved in this Recall
0591-3508-54Product
0591-3508-04Product
0591-3509-54Product
0591-3509-04Product
0591-3510-54Product
0591-3510-04Product
Class II Ongoing
CGMP Deviations: use of an unapproved raw material
Mar 19, 2026
Apr 15, 2026
113,943 Cartons
Recall Profile & Regulatory Data
Event ID
98614
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Within U.S
Product Description
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
Batch or Lot Expiration Information
Lot# Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
Affected Packages Involved in this Recall
0591-3508-54Product
0591-3508-04Product
0591-3509-54Product
0591-3509-04Product
0591-3510-54Product
0591-3510-04Product
Class II Ongoing
CGMP Deviations: use of an unapproved raw material
Mar 19, 2026
Apr 15, 2026
62,136 Cartons
Recall Profile & Regulatory Data
Event ID
98614
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Within U.S
Product Description
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
Batch or Lot Expiration Information
Lot# Lot: 100060002, Exp.: 07/2026; 100066802, Exp.: 05/2027
Affected Packages Involved in this Recall
0591-3508-54Product
0591-3508-04Product
0591-3509-54Product
0591-3509-04Product
0591-3510-54Product
0591-3510-04Product
October 2021 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications
Oct 28, 2021
Nov 24, 2021
64,978 patches
Recall Profile & Regulatory Data
Event ID
88938
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Feb 27, 2023
Product Description
Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04
Batch or Lot Expiration Information
Lot# 1369117B, exp. date 11/2021
Affected Packages Involved in this Recall
0591-3508-54Product
0591-3508-04Product
0591-3509-54Product
0591-3509-04Product
0591-3510-54Product
0591-3510-04Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
