Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Teva Pharmaceuticals USA, Inc

NDC code

0591-3508-04

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0472-2026

Other Clonidine recalls

See all

Class II · Moderate risk Ongoing Mar 19, 2026

Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by…

Reason CGMP Deviations: use of an unapproved raw material

Teva Pharmaceuticals USA, Inc NDC 0591-3510-04 D-0474-2026

Class II · Moderate risk Ongoing Mar 19, 2026

Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by…

Reason CGMP Deviations: use of an unapproved raw material

Teva Pharmaceuticals USA, Inc NDC 0591-3509-04 D-0473-2026

Class II · Moderate risk Ongoing Oct 10, 2025

R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50…

Reason Presence of Particulate Matter

QuVa Pharma, Inc. NDC 70092-1433-50 D-0113-2026

Class II · Moderate risk Ongoing Apr 26, 2023

Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use…

Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. D-0784-2023

Class III · Low risk Terminated Sep 19, 2022

Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind…

Reason Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,

Unichem Pharmaceuticals USA INC NDC 29300-137-01 D-1541-2022