Teva Pharmaceuticals recalls Clonidine Transdermal System due to use of unapproved raw material. Affected units have specific NDC numbers and expiration dates. Consumers should contact the manufacturer for details.
CGMP Deviations: use of an unapproved raw material
Teva Pharmaceuticals is recalling Clonidine Transdermal System patches because they were made with an unapproved raw material. This could lead to unsafe drug levels in patients. The recall affects specific batches with known NDC numbers and expiration dates.
The patches were made using an unapproved raw material, which could result in inconsistent drug levels. This might cause ineffective treatment or unexpected side effects. The exact risk level isn't specified in the recall notice.
People who have the specific Clonidine Transdermal System patches with NDC numbers 0591-3508-04 or 0591-3508-54 are affected. Those using prescription medication for hypertension or anxiety are most at risk.
Check for NDC numbers 0591-3508-04 (carton) or 0591-3508-54 (pouch) on the packaging. The expiration dates for these batches are April 2026 and January 2027.
Look for NDC numbers 0591-3508-04 or 0591-3508-54 on the packaging to confirm if your product is affected.
The recall is due to use of an unapproved raw material during manufacturing, which could affect drug safety.
The recall notice does not specify a remedy, so contact Teva Pharmaceuticals for further instructions.
Yes, batches with NDC numbers 0591-3508-04 and 0591-3508-54 are affected, with expiration dates April 2026 and January 2027.
We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0472-2026 — Teva Pharmaceuticals Teva Pharmaceuticals Hello, I own a Teva Pharmaceuticals that is covered by recall D-0472-2026 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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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.
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