Is Nystatin recalled?

29 FDA recalls mention Nystatin. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Nystatin.

Class II · Moderate risk Ongoing Jun 23, 2026

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

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

Padagis US LLC NDC 45802-059-35 D-0677-2026

Class II · Moderate risk Ongoing Dec 11, 2023

NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. -…

Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc NDC 51552-0041-1 D-0157-2024

Class II · Moderate risk Ongoing Dec 11, 2023

NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. -…

Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc NDC 51552-0041-4 D-0156-2024

Class II · Moderate risk Ongoing Dec 11, 2023

NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. -…

Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc NDC 51552-0041-3 D-0155-2024

Class II · Moderate risk Ongoing Dec 11, 2023

NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400…

Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc NDC 51552-0041-5 D-0154-2024

Class II · Moderate risk Terminated Mar 15, 2022

Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes, NDC…

Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Teligent Pharma, Inc. NDC 52565-042-15 D-0695-2022

Class II · Moderate risk Terminated Jul 29, 2021

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

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

PAI Holdings, LLC. dba Pharmaceutical Associates Inc NDC 0121-0868-16 D-0721-2021

Class III · Low risk Terminated Sep 25, 2020

NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL)…

Reason Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot

VistaPharm, Inc. NDC 66689-008-16 D-0019-2021

Class II · Moderate risk Terminated Aug 4, 2020

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

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

PAI Holdings, LLC. dba Pharmaceutical Associates Inc NDC 0121-0810-16 D-1494-2020

Class III · Low risk Terminated Jun 23, 2020

Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx…

Reason Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.

VistaPharm, Inc. NDC 66689-008-16 D-1378-2020

Class III · Low risk Terminated Jun 23, 2020

Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a)…

Reason Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.

VistaPharm, Inc. NDC 66689-037-50 D-1377-2020

Class II · Moderate risk Terminated Jun 10, 2020

Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson…

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

Crown Laboratories NDC 0316-0221-15 D-1339-2020

Class II · Moderate risk Terminated Jun 10, 2020

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

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

Crown Laboratories NDC 0316-0221-30 D-1338-2020

Class II · Moderate risk Terminated Mar 19, 2020

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

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

PAI Holdings, LLC. dba Pharmaceutical Associates Inc NDC 0121-0810-16 D-1060-2020

Class II · Moderate risk Terminated Jan 14, 2020

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

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

Pharmaceutical Associates Inc NDC 0121-0810-16 D-0824-2020

Class III · Low risk Terminated Jul 17, 2019

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

Reason Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability…

Lupin Pharmaceuticals Inc. NDC 68180-545-01 D-1518-2019

Class III · Low risk Terminated Mar 28, 2019

Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY…

Reason Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.

Akorn, Inc. NDC 50383-587-16 D-1080-2019

Class III · Low risk Terminated Nov 30, 2018

NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per…

Reason Failed Impurities/Degradation Specifications:Out of specification for impurities.

VistaPharm, Inc. NDC 66689-037-50 D-0348-2019

Class II · Moderate risk Terminated Sep 21, 2018

Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g…

Reason Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability…

Dr. Reddy's Laboratories, Inc. NDC 43598-431-44 D-0007-2019

Class III · Low risk Terminated May 29, 2018

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

Reason Resuspension problems: Out of specification for appearance and resuspendability.

Pharmaceutical Associates Inc NDC 0121-4810-05 D-0865-2018

Class II · Moderate risk Terminated May 17, 2017

Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61

Reason Presence of Foreign Substance: potential presence of plastic particles.

X-Gen Pharmaceuticals Inc. NDC 42543-052-61 D-1059-2017

Class III · Low risk Terminated May 17, 2017

Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL…

Reason Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.

VistaPharm, Inc. NDC 66689-008-02 D-0869-2017

Class II · Moderate risk Terminated Mar 28, 2017

Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a)…

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

Taro Pharmaceuticals U.S.A., Inc. NDC 51672-1263-1 D-0676-2017

Class II · Moderate risk Terminated Jan 18, 2017

Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit…

Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

VistaPharm, Inc. NDC 66689-037-99 D-0461-2017

Class II · Moderate risk Terminated Jan 18, 2017

Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz…

Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

VistaPharm, Inc. NDC 66689-008-02 D-0457-2017

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