Recall Weekly
Moderate riskFDA DrugClass II

Teva clonidine patches recalled for unapproved raw material use

Teva Pharmaceuticals is recalling certain Clonidine Transdermal System patches (0.1 mg/day) because they were manufactured using an unapproved raw material that does not meet FDA standards. The affected patches were distributed in the U.S. The company and FDA are working to ensure the product is removed from use.

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

What to do

  1. Check if your Clonidine patch is from lot 100060315 (expires 04/2026) or lot 100068644 (expires 01/2027)
  2. Do not stop taking your medication without talking to your doctor
  3. Contact your pharmacy or doctor immediately if you have one of the affected patches
  4. Your doctor can provide an alternative blood pressure medication or a replacement supply
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Clonidine Transdermal System, USP, 0.1 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 0591-3508-04 carton, NDC 0591-3508-54 pouch
Sold in
Nationwide
Made for
Adults

This recall covers 3 products — see all of them.

Details

Units affected
124,054 Cartons
Illnesses reported
None reported
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Classification
Class II
Recall number
D-0472-2026

In the FDA's words

Description
Clonidine Transdermal System, USP, 0.1 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 0591-3508-04 carton, NDC 0591-3508-54 pouch CGMP Deviations: use of an unapproved raw material Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027. Distribution: Within U.S Affected quantity: 124,054 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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