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Nystatin

FDA recalls

6 rows

Date	Company and reason	Class
Jun 22, 2026	Padagis US LLC Subpotent Drug: Low out of specification assay results performed during long-term stability testing.	Class II · Ongoing
Jul 28, 2021	Pai Holdings, LLC. dba Pharmaceutical Associates Inc Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.	Class II · Terminated
Aug 3, 2020	Pai Holdings, LLC. dba Pharmaceutical Associates Inc Subpotent drug: Out of specification for assay at the 15-month test interval.	Class II · Terminated
Mar 18, 2020	Pai Holdings, LLC. dba Pharmaceutical Associates Inc SubPotent Drug: Low out-of-specification results for assay testing.	Class II · Terminated
Jan 13, 2020	Pharmaceutical Associates Inc Subpotent: Out of specification for assay at the 12-month time point.	Class II · Terminated
May 28, 2018	Pharmaceutical Associates Inc Resuspension problems: Out of specification for appearance and resuspendability.	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).