NYSTATIN

Generic: NYSTATIN

Macleods Pharmaceuticals LimitedManufacturer

TOPICALRoute

NYSTATINActive Substance

2021-08-10Original Approval

NYSTATIN is FDA application ANDA213566, sponsored by MACLEODS PHARMS. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2020-01-14

Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceut

Subpotent: Out of specification for assay at the 12-month time point.

Class II2020-06-10

Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc

Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.

Class II2017-03-28

Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distribute

Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability

Class II2020-08-04

Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutic

Subpotent drug: Out of specification for assay at the 15-month test interval.

Class III2018-05-29

Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmace

Resuspension problems: Out of specification for appearance and resuspendability.

Class II2020-03-19

Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Ph

SubPotent Drug: Low out-of-specification results for assay testing.

Class II2021-07-29

Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL)

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Not Yet Classified2026-09-14

Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Di

Failed Stability Specifications

Class II2026-06-23

Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Isr

Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

Class III2019-07-17

Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmac

Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of cont

NYSTATIN

Recalls

Top Reported Reactions