FDA Recall D-0474-2026

Teva Pharmaceuticals USA, Inc · Parsippany, NJ

Class II Ongoing 56 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.

Quantity: 113,943 Cartons

Reason for recall

CGMP Deviations: use of an unapproved raw material

Recall record

Recall number: D-0474-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Within U.S
Recall initiated: 2026-03-19
Classified by FDA Center: 2026-04-13
FDA published: 2026-04-15
Recalling firm: Teva Pharmaceuticals USA, Inc
Firm location: Parsippany, NJ

Drug identification

Brand name(s): CLONIDINE TRANSDERMAL SYSTEM
Generic name(s): CLONIDINE
Manufacturer(s): Actavis Pharma, Inc.
NDC(s): 0591-3508, 0591-3509, 0591-3510
Route(s): TRANSDERMAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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