Nystatin recalls: 6 FDA reports
Recalls involving Nystatin. What was wrong with each batch, and how the FDA graded the risk.
6Reports
0Class I
1Ongoing
2026-07-22Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Ye
D-0677-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
- Product
- Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35
- Where it went
- USA Nationwide
- How much
- 180,936 tubes
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl o
D-0721-2021 · Class II · reported 2021-08-18 · Terminated
- Why it was recalled
- Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
- Product
- Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605
- Where it went
- Distributed Nationwide in the USA
- How much
- a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Ph
D-1494-2020 · Class II · reported 2020-08-19 · Terminated
- Why it was recalled
- Subpotent drug: Out of specification for assay at the 15-month test interval.
- Product
- Nystatin 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 0121-0810-16
- Where it went
- Nationwide USA
- How much
- 7416 bottles
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ON
D-1060-2020 · Class II · reported 2020-04-01 · Terminated
- Why it was recalled
- SubPotent Drug: Low out-of-specification results for assay testing.
- Product
- Nystatin 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.
- Where it went
- Nationwide in the USA.
- How much
- 7416 bottles
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai,
D-0824-2020 · Class II · reported 2020-02-05 · Terminated
- Why it was recalled
- Subpotent: Out of specification for assay at the 12-month time point.
- Product
- Nystatin 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 0121-0810-16
- Where it went
- Distributed Nationwide in the US
- How much
- 6288 16 oz bottles
Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only
D-0865-2018 · Class III · reported 2018-06-13 · Terminated
- Why it was recalled
- Resuspension problems: Out of specification for appearance and resuspendability.
- Product
- Nystatin 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 0121-4810-05
- Where it went
- Nationwide
- How much
- 275400 cups
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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