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Clonidine

FDA recalls

5 rows

Date	Company and reason	Class
Mar 18, 2026	Teva Pharmaceuticals USA, Inc CGMP Deviations: use of an unapproved raw material	Class II · Ongoing
Jun 8, 2022	Mayne Pharma Inc Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.	Class II · Terminated
Oct 27, 2021	Teva Pharmaceuticals USA Failed Impurities/Degradation Specifications	Class III · Terminated
Mar 28, 2019	X-Gen Pharmaceuticals Inc. Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.	Class III · Terminated
Jul 16, 2014	X-Gen Pharmaceuticals Inc. Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".	Class III · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).