D-0474-2026 Class II Ongoing
FDA drug recall D-0474-2026 was initiated by Teva Pharmaceuticals USA, Inc on Mar 19, 2026 and is designated Class II. Reason for recall: CGMP Deviations: use of an unapproved raw material The recall status is ongoing. Affected quantity: 113,943 Cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 15, 2026
- Initiation Date
- Mar 19, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 113,943 Cartons
Product Description
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 for Recall
CGMP Deviations: use of an unapproved raw material
Distribution Pattern
Within U.S
Code Information
Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0474-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026