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
- Multiple Retailers
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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 Clonidine System
- Model numbers
- Lot: 100053892, Exp.: 04/2026, 100057899, Exp.: 05/2026, 100062704, Exp.: 02/2027.
- 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
- 0.3 mg/day
- Sold at
- Multiple Retailers
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 system delivers clonidine through the skin to treat high blood pressure and certain other conditions.
Why This Is Dangerous
CGMP deviations indicate an unapproved raw material was used in production, which could affect drug quality and safety.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
No targeted injuries reported in the notice; however, the recall emphasizes quality control risk and potential unsafe drug product.
Practical Guidance
How to identify if yours is affected
- Check the carton for NDC 0591-3510-04 or 0591-3510-54
- Check expiration dates: Exp. 04/2026, Exp. 05/2026, Exp. 02/2027
Where to find product info
NDC numbers printed on carton and pouch; lot numbers on carton seals and foil packaging
What timeline to expect
No remediation timeframe provided in the notice; expect recall communications by Teva and FDA updates
If the manufacturer is unresponsive
- Document all communications
- Escalate to FDA consumer complaint if needed
- Seek guidance from healthcare provider for alternative therapy
How to prevent similar issues
- Verify CGMP compliance when purchasing drug products
- Only use drug products from reputable pharmacies
- Report any unusual drug quality issues to FDA/CPSc
Documentation advice
Keep recall notice, lot numbers, expiration dates, and any correspondence with manufacturer.
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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 0591-3510-04 carton, 0591-3510-54 pouch. Quantity: 113,943 cartons. Form: 0.3 mg/day transdermal system. Pack: cartons of 4 Systems and 4 Adhesive Covers. Route: Rx only. Distribution: Within the U.S. Models/lot information in play: Lot 100053892 (Exp. 04/2026), Lot 100057899 (Exp. 05/2026), Lot 100062704 (Exp. 02/2027). Dates: Recall date 2026-03-19. Status: ACTIVE.
Reported Incidents
No specific injuries or incidents are described in the provided recall notice.
Key Facts
- Cartons contain 4 System units and 4 Adhesive Covers
- NDC 0591-3510-04 and NDC 0591-3510-54
- Recall date: 2026-03-19; Status: ACTIVE
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Safety Guide
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