Teva Clonidine Transdermal System Recall: Unapproved Raw Material Risk

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Recalling firmTeva Pharmaceuticals USA, Inc400 Interpace Pkwy Bldg A · Parsippany, NJ 07054-1120

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Teva Pharmaceuticals is recalling Clonidine Transdermal Systems because they used an unapproved raw material during manufacturing. This could lead to potential safety issues with the medication. Affected products have specific NDC numbers and expiration dates.

Why it’s dangerous

The medication was made using an unapproved raw material, which could affect its safety and effectiveness. This deviation in manufacturing might lead to potential health risks if the medication is used as intended.

Who’s affected

People who have the Clonidine Transdermal System with NDC numbers 0591-3510-04 or 0591-3510-54 and expiration dates up to 04/2026 or 05/2026 or 02/2027 are affected. Those using this medication for blood pressure control are most at risk.

How to tell if you have this one

Check the NDC numbers on the product: 0591-3510-04 or 0591-3510-54. The expiration dates for these products range from 04/2026 to 02/2027. The product is a prescription-only medication.

Brand
Teva Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for NDC numbers 0591-3510-04 or 0591-3510-54 on the product packaging.

✎ GovInfoNow

Questions people ask

What is the recall about?

Teva Pharmaceuticals is recalling Clonidine Transdermal Systems due to use of an unapproved raw material during manufacturing.

How can I tell if I have the recalled product?

Check the NDC numbers: 0591-3510-04 or 0591-3510-54. The expiration dates range from 04/2026 to 02/2027.

What should I do if I have the recalled product?

The recall record does not specify a remedy, so contact Teva Pharmaceuticals for further instructions.

Take action

Contact Teva Pharmaceuticals

We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0474-2026 — Teva Pharmaceuticals Teva Pharmaceuticals

Hello,

I own a Teva Pharmaceuticals that is covered by recall D-0474-2026 from Teva Pharmaceuticals.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0474-2026 (March 19, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0474-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Teva Pharmaceuticals USA, Inc recalls Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only,

Recall notice