FDA Drug recall D-0235-2022
Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City…
- FDA Drug
- Class III
- terminated
- Published 2021-11-24
On 2021-11-24 the FDA classified a Class III recall of Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City… by Teva Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0235-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-10-28 |
| Published | 2021-11-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04
Reason
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 0591-3508-54 |
|---|---|
| ndc | 0591-3508-04 |
| ndc | 0591-3509-54 |
| ndc | 0591-3509-04 |
| ndc | 0591-3510-54 |
| ndc | 0591-3510-04 |
| code_info | Lot# 1369117B, exp. date 11/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0235-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.