CLASS III Drug recall · Reported 13 Jun 2018 · FDA Enforcement Report
Nystatin Oral Suspension, USP, For Institutional Use Only recalled
Pharmaceutical Associates is recalling Nystatin Oral Suspension, USP, For Institutional Use Only, distributed nationwide in the US. The recall was initiated on 29 May 2018 and the FDA has classified it as Class III.
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-0865-2018
- FDA event ID
- 80190
- Recalling firm
- Pharmaceutical Associates, Greenville, SC
- Brand
- Nystatin
- Manufacturer
- Pharmaceutical Associates, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 May 2018
- FDA classified
- 13 Jun 2018
- Reported
- 13 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 29 May 2018 | Recall initiated by company | |
| 13 Jun 2018 | Classified by FDA | +15 days |
| 13 Jun 2018 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Resuspension problems: Out of specification for appearance and resuspendability.
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 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 was distributed
Nationwide
Questions about this recall
Why was it recalled?
Resuspension problems: Out of specification for appearance and resuspendability.
Which lots are affected?
Lot: B5B8 Exp. 07/2019
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Pharmaceutical Associates
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nystatin Oral Suspension, USP per mL Cherry/Peppermint Flavor recalledNystatin | Pharmaceutical Associates | Potency & Assay | Nationwide |
| Drug | CLASS II | Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg recalled | Pharmaceutical Associates | 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 |