---
title: "Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Syste... — FDA record D-0473-2026 | Is It on Recall"
description: "CGMP Deviations: use of an unapproved raw material"
url: https://isitonrecall.com/recall/fda-drug-d-0473-2026-clonidine-transdermal-system-usp-0-2-mg-day-supplied-in-cartons-of-4-systems-and-4-adhesive-covers-r/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manuf... — FDA record D-0473-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 19, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 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
- **Reason**: CGMP Deviations: use of an unapproved raw material
- **Classification**: Class II
- **Recalling firm**: Teva Pharmaceuticals USA, Inc
- **Quantity**: 62,136 Cartons
- **Agency-reported status**: Ongoing
- **Source record identifier**: D-0473-2026

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0473-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot: 100060002, Exp.: 07/2026; 100066802, Exp.: 05/2027 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Within U.S

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Apr 15, 2026
- **Recall initiation date**: Mar 19, 2026
- **Center classification date**: Apr 13, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0473-2026%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Teva Pharmaceuticals USA Inc records](https://isitonrecall.com/brand/teva-pharmaceuticals-usa-inc/)