Moderate riskFDA DrugClass II

Teva clonidine transdermal system recalled for unapproved raw material

Teva Pharmaceuticals is recalling specific lots of Clonidine Transdermal System (0.2 mg/day) patches because they were made with an unapproved raw material that does not meet manufacturing standards. Two lots are affected: 100060002 (expires 07/2026) and 100066802 (expires 05/2027). No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Teva recalls

What to do

  1. Check if your Clonidine patch matches lot 100060002 or 100066802
  2. If it does, contact your pharmacy or doctor before stopping the medication
  3. Do not suddenly stop using Clonidine without medical guidance, as this can cause serious blood pressure changes
  4. Ask your pharmacist for a replacement from a non-recalled lot

Is yours affected?

Compare your label or packaging with the recalled product.

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
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
62,136 Cartons
Illnesses reported
None reported
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Classification
Class II
Recall number
D-0473-2026

In the FDA's words

Description
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 CGMP Deviations: use of an unapproved raw material Lot: 100060002, Exp.: 07/2026; 100066802, Exp.: 05/2027 Distribution: Within U.S Affected quantity: 62,136 Cartons
Hazard
CGMP Deviations: use of an unapproved raw material

3 products in this recall

The agency lists each product separately. Check every one you might have.

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