Recall Weekly
Moderate riskFDA DrugClass II

Teva clonidine patches recalled for unapproved raw material

Teva Pharmaceuticals is recalling specific batches of Clonidine Transdermal System patches (0.3 mg/day) because they were manufactured using an unapproved raw material that does not meet quality standards. The affected patches were distributed in the U.S. 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 one of these lot numbers: 100053892 (exp. 04/2026), 100057899 (exp. 05/2026), or 100062704 (exp. 02/2027).
  2. If you have a recalled patch, contact your pharmacy or doctor before stopping your medication.
  3. Return the recalled patches to your pharmacy.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Clonidine Transdermal System, USP, 0.3 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 0591-3510-04 carton, NDC 0591-3510-54 pouch
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
113,943 Cartons
Illnesses reported
None reported
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Classification
Class II
Recall number
D-0474-2026

In the FDA's words

Description
Clonidine Transdermal System, USP, 0.3 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 0591-3510-04 carton, NDC 0591-3510-54 pouch CGMP Deviations: use of an unapproved raw material Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027. Distribution: Within U.S Affected quantity: 113,943 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.

More from Teva

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