CLASS II Drug recall · Reported 10 Feb 2016 · FDA Enforcement Report
Nystatin, USP Powder for Rx compounding, 150 Million Units recalled
Perrigo is recalling Nystatin, USP Powder for Rx compounding, 150 Million Units, distributed nationwide in the US. The recall was initiated on 18 Jan 2016 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-0652-2016
- FDA event ID
- 73101
- Recalling firm
- Perrigo, Allegan, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jan 2016
- FDA classified
- 4 Feb 2016
- Reported
- 10 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Compounded Drugs
Timeline
| 18 Jan 2016 | Recall initiated by company | |
| 4 Feb 2016 | Classified by FDA | +17 days |
| 10 Feb 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: label error on declared strength.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: label error on declared strength.
Which lots are affected?
Lot #: 2015080484, Exp 02/2016
Where was it sold?
Nationwide
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 73101This product is part of a recall event; the main page for the event is Nystatin, USP Powder for Rx compounding, 50 Million Units recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Nystatin, USP Powder for Rx compounding, 50 Million Units recalled | Perrigo | Packaging Defects | Nationwide |
More recalls from Perrigo
All 106| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Children's Pain & Fever Acetaminophen recalled by Perrigo Company | Perrigo | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Children's Cherry Flavored Acetaminophen Oral Suspension (160mg recalled | Perrigo | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nasal Spray Decongestant, No Drip, Oxymetazoline HCl recalledNasal | Perrigo | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Acetaminophen Oral Suspension Grape Flavor, 160 mg recalled | Perrigo | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Maximum Strength Nasal Spray recalled by Perrigo CompanyNasal | Perrigo | Manufacturing (CGMP) Deviations | 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 |