CLASS II Drug recall · Reported 1 Apr 2020 · FDA Enforcement Report
Nystatin Oral Suspension, USP per mL, Cherry/Peppermint Flavor recalled
PAI Holdings is recalling Nystatin Oral Suspension, USP per mL, Cherry/Peppermint Flavor, distributed nationwide in the US. The recall was initiated on 19 Mar 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-1060-2020
- FDA event ID
- 85302
- Recalling firm
- PAI Holdings, Greenville, SC
- Brand
- Nystatin
- Manufacturer
- Pharmaceutical Associates, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Mar 2020
- FDA classified
- 25 Mar 2020
- Reported
- 1 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 19 Mar 2020 | Recall initiated by company | |
| 25 Mar 2020 | Classified by FDA | +6 days |
| 1 Apr 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: Low out-of-specification results for assay testing.
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) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
SubPotent Drug: Low out-of-specification results for assay testing.
Which lots are affected?
Lot: BE85, Exp. 11/2020
Where was it sold?
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.
More recalls from PAI Holdings
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | VistaPharm, Kerr Insta-char IN AN Sorbitol Base With Cherry recalled | PAI Holdings | Other | Nationwide |
| Drug | CLASS II | VistaPharm, Kerr Insta-char IN AN Aqueous Base With Cherry recalled | PAI Holdings | Other | Nationwide |
| Drug | CLASS II | VistaPharm, Kerr Insta-char IN AN Sorbitol Base With Cherry recalled | PAI Holdings | Other | Nationwide |
| Drug | CLASS II | VistaPharm, Kerr Insta-char IN AN Aqueous Base With Cherry recalled | PAI Holdings | Other | Nationwide |
| Drug | CLASS III | Guaifenesin and Codeine Phosphate Oral Solution recalled by PAI HoldingsGuaifenesin And Codeine Phosphate | PAI Holdings | Potency & Assay | OH |
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 |