CLASS II Drug recall · Reported 5 Feb 2020 · FDA Enforcement Report
Nystatin Oral Suspension, USP per mL Cherry/Peppermint Flavor recalled
Pharmaceutical Associates is recalling Nystatin Oral Suspension, USP per mL Cherry/Peppermint Flavor, distributed nationwide in the US. The recall was initiated on 14 Jan 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-0824-2020
- FDA event ID
- 84712
- Recalling firm
- Pharmaceutical Associates, Greenville, SC
- Brand
- Nystatin
- Manufacturer
- Pharmaceutical Associates, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jan 2020
- FDA classified
- 3 Feb 2020
- Reported
- 5 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 14 Jan 2020 | Recall initiated by company | |
| 3 Feb 2020 | Classified by FDA | +20 days |
| 5 Feb 2020 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent: Out of specification for assay at the 12-month time point.
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 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 was distributed
Distributed Nationwide in the US
Questions about this recall
Why was it recalled?
Subpotent: Out of specification for assay at the 12-month time point.
Which lots are affected?
Lots: BB70, BB71 Exp. May 2020
Where was it sold?
Distributed Nationwide in the US
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.
More recalls from Pharmaceutical Associates
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Nystatin Oral Suspension, USP, For Institutional Use Only 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 |