Recall archive / FDA drug enforcement
Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manuf... — FDA record D-0474-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 19, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- CGMP Deviations: use of an unapproved raw material
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Quantity
- 113,943 Cartons
- Agency-reported status
- Ongoing
- Source record identifier
- D-0474-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Within U.S
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 15, 2026
- Recall initiation date
- Mar 19, 2026
- Center classification date
- Apr 13, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.