FDA Drug Recalls

Recalls / Active ingredient / Nystatin

Nystatin

9 FDA drug recalls involving the active ingredient “Nystatin.

DateClassProductFirm
2021-07-29Class IINystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oPAI Holdings, LLC. dba Pharmaceutical Associates Inc
2020-08-04Class IINystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, PhPAI Holdings, LLC. dba Pharmaceutical Associates Inc
2020-06-10Class IINystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown LaboratCrown Laboratories
2020-06-10Class IINystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown LaboratoCrown Laboratories
2020-03-19Class IINystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONPAI Holdings, LLC. dba Pharmaceutical Associates Inc
2020-01-14Class IINystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates Inc
2019-07-17Class IIINystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: LupLupin Pharmaceuticals Inc.
2018-05-29Class IIINystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx OnlyPharmaceutical Associates Inc
2017-03-28Class IINystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, Taro Pharmaceuticals U.S.A., Inc.