Clonidine Transdermal System — Class II drug recall D-0473-2026
Ongoing recall by Teva Pharmaceuticals USA, Inc, reported 2026-04-15. CGMP Deviations: use of an unapproved raw material
| Recall number | D-0473-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc, Parsippany, NJ, United States |
| Recall initiated | 2026-03-19 |
| Classified | 2026-04-13 |
| Reported by FDA | 2026-04-15 |
| Quantity | 62,136 cartons |
| Reason classes | cgmp, unapproved product |
| 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 | 100060002, 100066802 |
| Expiration dates | 2026-07, 2027-05 |
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
Reason for recall
CGMP Deviations: use of an unapproved raw material
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-0473-2026. 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.