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
- Check if your Clonidine patch matches lot 100060002 or 100066802
- If it does, contact your pharmacy or doctor before stopping the medication
- Do not suddenly stop using Clonidine without medical guidance, as this can cause serious blood pressure changes
- 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.
- 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.…D-0472-2026 · 124,054 Cartons
- 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.… (this page)D-0473-2026 · 62,136 Cartons
- 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.…D-0474-2026 · 113,943 Cartons
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