HIGHFDA DRUG

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...

CGMP Deviations: use of an unapproved raw material

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
March 19, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
March 19, 2026
Hazard Level
HIGH
Brands
CLONIDINE TRANSDERMAL SYSTEM, Actavis Pharma, Inc.

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
CLONIDINE TRANSDERMAL SYSTEM, Actavis Pharma, Inc.
Model numbers
Lot: 100060002, Exp.: 07/2026, 100066802, Exp.: 05/2027
UPC codes
0591-3508, 0591-3509, 0591-3510, 0591-3508-54, 0591-3508-04, 0591-3509-54, 0591-3509-04, 0591-3510-54 +1 more

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    March 19, 2026

  2. Reported by FDA DRUG

    April 15, 2026

  3. RecallRadar source check

    April 22, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

CGMP Deviations: use of an unapproved raw material

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. Notification method: Letter

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Full 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. Generic: CLONIDINE; Brand: CLONIDINE TRANSDERMAL SYSTEM. Reason: CGMP Deviations: use of an unapproved raw material. Classification: Class II. Quantity: 62,136 Cartons. Distribution: Within U.S

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Lot: 100060002
Exp.: 07/2026
100066802
Exp.: 05/2027
UPC Codes
0591-3508
0591-3509
0591-3510
+6 more
Report Date
April 15, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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