Quick Facts at a Glance
- Recall Date
- March 19, 2026
- Hazard Level
- HIGH
- Brands
- CLONIDINE TRANSDERMAL SYSTEM, Actavis Pharma, Inc.
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- CLONIDINE TRANSDERMAL SYSTEM, Actavis Pharma, Inc.
- Product type
- Transdermal system (Medication)
- Model numbers
- Lot: 100060315, Exp.: 04/2026, 100068644, Exp.: 01/2027.
- UPC codes
- 0591-3508, 0591-3509, 0591-3510, 0591-3508-54, 0591-3508-04, 0591-3509-54, 0591-3509-04, 0591-3510-54 +1 more
- Sizes
- 0.1 mg/day patch
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 19, 2026
Reported by FDA DRUG
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
CGMP Deviations: use of an unapproved raw material
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. Notification method: Letter
About This Product
Clonidine transdermal systems deliver a controlled amount of clonidine for hypertension management. They are prescribed and distributed to pharmacies and clinics.
Why This Is Dangerous
CGMP deviations indicate use of an unapproved raw material, which could lead to quality or safety concerns.
Industry Context
This recall is not necessarily part of a broader pattern but highlights CGMP deviations in drug manufacturing.
Real-World Impact
Direct impact on patients and clinics; potential disruption of therapy and need for immediate cessation and medical guidance.
Practical Guidance
How to identify if yours is affected
- Verify lot numbers 100060315 and 100068644.
- Check expiration dates 04/2026 and 01/2027.
Where to find product info
Recall notification letter and FDA enforcement page D-0472-2026.
What timeline to expect
Refunds or replacements described in recall letters; typically several weeks.
If the manufacturer is unresponsive
- Escalate to pharmacist or healthcare provider.
- Contact Teva Pharmaceuticals USA, Inc or distributor as indicated in recall notice.
- File a formal consumer complaint with FDA if needed.
How to prevent similar issues
- Verify CGMP compliance when sourcing drug products.
- Watch for recall notices tied to manufacturing deviations.
- Rely on pharmacies and clinics for stock verification.
Documentation advice
Keep recall notice, lot numbers, NDCs, expiration dates, and correspondence with suppliers.
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Product Details
Brand: CLONIDINE TRANSDERMAL SYSTEM. Manufacturer: Actavis Laboratories UT Inc., Salt Lake City, UT 84108. Distributor: Teva Pharmaceuticals USA, Inc. NDC 0591-3508-04 carton, NDC 0591-3508-54 pouch. Quantity: 124,054 cartons. Status: Active recall as of 2026-03-19. Distribution: Within the U.S.
Reported Incidents
No specific injuries or incidents are listed in the provided data.
Key Facts
- Lot: 100060315 and Lot: 100068644
- Exp. dates: 04/2026 and 01/2027
- Manufacturer: Actavis Laboratories UT Inc., Salt Lake City, UT
- Distributor: Teva Pharmaceuticals USA, Inc.
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Safety Guide
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