Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Is Clonidine recalled?
Yes — there is an active recall. 4 ongoing FDA recalls mention Clonidine (92 total). Check the affected lots below.
Most common reason: Sterility / contamination (46 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Clonidine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Clonidine recalls in 2026
3 initiated in 2026, 92 in total — newest first
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk
R.E.C.K.
Presence of Particulate Matter
Class III · Low risk
Clonidine Hydrochloride Tablets
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Class II · Moderate risk
Ropivacaine HCl 123 mg
Lack of Assurance of Sterility
Class II · Moderate risk
Clonidine Transdermal System
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Class II · Moderate risk
Duraclon (clonidine HCl injection, USP)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Clonidine Hydrochloride Tablets
cGMP deviations: Temperature abuse
Class III · Low risk
Clonidine Transdermal System
Failed Impurities/Degradation Specifications
Class I · High risk
Class II · Moderate risk
Catapres (clonidine hydrochloride, USP)
An extraneous peak was observed for dissolution testing.
Class II · Moderate risk
Catapres (clonidine hydrochloride, USP)
An extraneous peak was observed for dissolution testing.
Class II · Moderate risk
Catapres (clonidine hydrochloride, USP)
An extraneous peak was observed for dissolution testing.
Class III · Low risk
Clonidine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Class III · Low risk
R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac)
Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
Class III · Low risk
Clonidine Hydrochloride Tablets
Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.
Class II · Moderate risk
Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine…
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Baclofen and Clonidine HCL and Morphine Sulfate in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Morphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.