Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0473-2026·Announced 2026-04-15

Teva clonidine 0.2 mg patches recalled over unapproved raw material use

Teva is recalling two lots of Clonidine Transdermal System, USP, 0.2 mg/day, citing CGMP deviations involving the use of an unapproved raw material. 62,136 cartons are affected.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall arising from a manufacturing compliance deviation with no product-quality or health consequence described in the source, which places it at the precautionary Moderate level.

Plain-English summary

Teva Pharmaceuticals USA, Inc is recalling Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of four systems and four adhesive covers. The carton NDC is 0591-3509-04 and the pouch NDC is 0591-3509-54. The action covers 62,136 cartons.

The stated reason is current good manufacturing practice deviations, specifically the use of an unapproved raw material. The FDA classified the action as Class II. The source does not describe any resulting effect on the potency, purity or performance of the patches.

Affected lots are 100060002 (exp 07/2026) and 100066802 (exp 05/2027). Distribution was within the United States.

This is a prescription product. Patients should not stop using a prescribed medicine without advice; anyone holding an affected lot should contact their pharmacy or prescriber about a replacement supply.

The recalled product

Product: CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
Brand: CLONIDINE TRANSDERMAL SYSTEM
Manufacturer: Teva Pharmaceuticals USA, Inc
Category: Drug — Transdermal patch
Hazard: cgmp-deviation
unapproved-raw-material
class-ii
prescription-drug
Affected units: 62,136

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

Lot: 100060002
Exp.: 07/2026
100066802
Exp.: 05/2027

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Teva Pharmaceuticals USA, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same brand · CLONIDINE TRANSDERMAL SYSTEM

Moderate
Teva clonidine 0.3 mg patches recalled over unapproved raw material use
FDA (Drugs) · 2026-04-15
Moderate
Teva clonidine transdermal patches recalled over unapproved raw material use
FDA (Drugs) · 2026-04-15
Moderate
Clonidine Transdermal System patches recalled for impurities and degradation
FDA (Drugs) · 2021-11-24

Same manufacturer · Teva Pharmaceuticals USA, Inc

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Same hazard · cgmp deviation