CLASS II Drug recall · Reported 1 Jul 2020 · FDA Enforcement Report
Nystatin Cream, USP per gram recalled by Crown Laboratories
Crown Laboratories is recalling Nystatin Cream, USP per gram, distributed nationwide in the US. The recall was initiated on 10 Jun 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1339-2020
- FDA event ID
- 85833
- Recalling firm
- Crown Laboratories, Johnson City, TN
- Brand
- Nystatin Cream
- Manufacturer
- Crown Laboratories
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jun 2020
- FDA classified
- 24 Jun 2020
- Reported
- 1 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 10 Jun 2020 | Recall initiated by company | |
| 24 Jun 2020 | Classified by FDA | +14 days |
| 1 Jul 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-15
Where it was distributed
Distributed Nationwide in the USA.
Questions about this recall
Why was it recalled?
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Which lots are affected?
Lot: Y0378, EXP 07/2021
Where was it sold?
Distributed Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 85833This product is part of a recall event; the main page for the event is Nystatin Cream, USP per gram recalled by Crown Laboratories.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Nystatin Cream, USP per gram recalled by Crown LaboratoriesNystatin Cream | Crown Laboratories | Potency & Assay | Nationwide |
More recalls from Crown Laboratories
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nystatin Cream, USP per gram recalled by Crown LaboratoriesNystatin Cream | Crown Laboratories | Potency & Assay | Nationwide |
Other Nystatin recalls
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nystatin Cream USP, (100,000 USP Nystatin Units) recalled by Padagis USNystatin | Padagis US | Potency & Assay | Nationwide |
| Drug | CLASS II | Nystatin and Triamcinolone Acetonide Ointment recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Nystatin Oral Suspension, USP per mL, Cherry/Peppermint Flavor recalledNystatin | PAI Holdings | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Nystatin Oral Suspension, USP per mL Contains recalled by VistaPharm | VistaPharm | Potency & Assay | Nationwide |
| Drug | CLASS II | Nystatin Oral Suspension, USP per mL, Cherry/Peppermint Flavor recalledNystatin | PAI Holdings | Potency & Assay | Nationwide |