Clonidine Transdermal System — Class III drug recall D-0235-2022
Terminated recall by Teva Pharmaceuticals USA, reported 2021-11-24, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0235-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2021-10-28 |
| Classified | 2021-11-16 |
| Reported by FDA | 2021-11-24 |
| Terminated | 2023-02-27 |
| Distributed | Nationwide (US) |
| Quantity | 64,978 patches |
| Reason classes | specification failure |
| NDC | 00591-3508, 00591-3508-04, 00591-3508-54, 00591-3509, 00591-3509-04, 00591-3509-54, 00591-3510, 00591-3510-04, 00591-3510-54 |
| Lot numbers | 1369117B |
| Expiration dates | 2021-11 |
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 for recall
Failed Impurities/Degradation Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0235-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.