CLASS II Drug recall · Reported 18 Aug 2021 · 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 29 Jul 2021 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-0721-2021
- FDA event ID
- 88392
- Recalling firm
- PAI Holdings, Greenville, SC
- Brand
- Nystatin
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jul 2021
- FDA classified
- 12 Aug 2021
- Reported
- 18 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 29 Jul 2021 | Recall initiated by company | |
| 12 Aug 2021 | Classified by FDA | +14 days |
| 18 Aug 2021 | 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
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Product as listed by the FDA
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Which lots are affected?
Lots: a) C98F, C990 Exp. 30SEP2022, C9C2 Exp. 31OCT2022; b) C9E1 Exp. 31OCT2022
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
2 other products · FDA event 88392This product is part of a recall event; the main page for the event is Ethosuximide Oral Solution USP 250 mg recalled by PAI Holdings.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ethosuximide Oral Solution USP 250 mg recalled by PAI HoldingsEthosuximide | PAI Holdings | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Cimetidine Hydrochloride Oral Solution 300 mg recalled by PAI Holdings | PAI Holdings | Manufacturing (CGMP) Deviations | Nationwide |
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 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 |
| Drug | CLASS III | Nystatin Oral Suspension, USP per mL, Bubblegum Flavored recalled | VistaPharm | Potency & Assay | PR |