FDA Recall of Clonidine Transdermal System Due to Manufacturing Issue

Source: FDA · United States

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Teva Pharmaceuticals USA, Inc. is voluntarily recalling 113,943 cartons of Clonidine Transdermal System because of CGMP deviations involving an unapproved raw material.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 22, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, Drugs) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Teva Pharmaceuticals USA, Inc. is recalling Clonidine Transdermal System due to CGMP deviations, specifically the use of an unapproved raw material. This is a Class II recall initiated voluntarily by the firm.

Which Products Are Affected

The affected product is Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers. It is a human prescription drug with NDC codes including 0591-3510-04 and 0591-3510-54. The recall involves 113,943 cartons from lots: 100053892 (expiration 04/2026), 100057899 (expiration 05/2026), and 100062704 (expiration 02/2027). Distribution was within the United States.

What You Should Do

Consumers who have the affected product should follow the initial firm notification, which was issued via letter, and contact Teva Pharmaceuticals USA, Inc. at their address: 400 Interpace Pkwy Bldg A, Parsippany, NJ 07054-1120, for further instructions on returns or refunds.

Why This Matters

This recall highlights potential risks from manufacturing deviations in prescription drugs, affecting product safety and requiring consumers to verify their medications. It underscores the importance of adhering to CGMP standards to ensure reliable healthcare products.

Source

This information is from the FDA recall notice with recall number D-0474-2026. For more details, refer to the FDA website.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Teva Pharmaceuticals USA, Inc. is voluntarily recalling 113,943 cartons of Clonidine Transdermal System because of CGMP deviations involving an unapproved raw material.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.