FDA Recall Nystatin

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Nystatin with NDC 0121-4810 was initiated on 08-04-2020 as a Class II recall due to subpotent drug: out of specification for assay at the 15-month test interval. The latest recall number for this product is D-1494-2020 and the recall is currently terminated as of 09-22-2021 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-1494-202008-04-202008-19-2020Class II7416 bottlesNystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16Terminated
D-1060-202003-19-202004-01-2020Class II7416 bottlesNystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.Terminated
D-0824-202001-14-202002-05-2020Class II6288 16 oz bottlesNystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16Terminated
D-0865-201805-29-201806-13-2018Class III275400 cupsNystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.