Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Crown Laboratories | Johnson City, TN, United States | Makes it | Problems found, fixed voluntarilySep 19, 2025 · 9 inspections, 2 with FDA action |
Recalls
- Jun 10, 2020 · Class II · Crown Laboratories
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Lots: Lot: Y0378A, EXP 07/2021 - Jun 10, 2020 · Class II · Crown Laboratories
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Lots: Lot: Y0378, EXP 07/2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Nystatin: every company that makes it
- Form
- cream, topical
- Strength
- 100000 [USP'U] per 1 g
- Approval
- ANDA ANDA207733
- On the market since
- Oct 10, 2017
- Package NDCs
0316-0221-150316-0221-30- Official label
- DailyMed (National Library of Medicine), updated Jan 12, 2026
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