Teva Clonidine Transdermal System Recall: Impurities May Cause Harm
Teva Pharmaceuticals USA recalls Clon: 0.1 mg/day patches due to failed impurities/degradation specs. Rx only. Check NDC 0591-3508-04 and lot 1369117B.
Lower-risk recall
Failed Impurities/Degradation Specifications
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What happened, in plain English
Teva Pharmaceuticals USA is recalling Clonidine Transdermal System patches (0.1 mg/day) because they may contain impurities or degrade improperly. This could lead to health risks if used as directed. Read more at govinfonow.com/recall/35580-teva-clonidine-transdermal-system-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/35580-teva-clonidine-transdermal-system-recall-impurities-may-cause-harm · Updated August 18, 2026 · FDA enforcement record: FDA #D-0235-2022
Cite this page
“Teva Clonidine Transdermal System Recall: Impurities May Cause Harm.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35580-teva-clonidine-transdermal-system-recall-impurities-may-cause-harm. Based on FDA recall #D-0235-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0235-2022%22&limit=1).
Why it’s dangerous
The patches may have impurities or degrade improperly, which could lead to health risks if used as directed. This is a quality control issue in the manufacturing process.
Who’s affected
People with prescriptions for Clonidine Transdermal System patches (0.1 mg/day) from the recall lot. Those using the product without a prescription are not affected.
How to tell if you have this one
Check for the NDC code 0591-3508-04 and lot number 1369117B on the packaging. The product is prescription-only and distributed by Actavis Pharma, Inc.
- Brand
Teva Pharmaceuticals USA- Category
Drug
What to do — step by step
Check Product Details
Look for NDC 0591-3508-04 and lot number 1369117B on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0235-2022 (October 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0235-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.