Clonidine Transdermal System recall: CGMP Deviations
Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch
Why was Clonidine Transdermal System recalled?
CGMP Deviations: use of an unapproved raw material
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 100060002, Exp.: 07/2026; 100066802, Exp.: 05/2027
- Product
- Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Quantity
- 62,136 Cartons
- Distribution
- Within U.S
- Recall date
- April 15, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)