Nystatin Oral Suspension — Class II drug recall D-1494-2020
Terminated recall by PAI Holdings, LLC. dba Pharmaceutical Associates Inc, reported 2020-08-19, distributed nationwide. Subpotent drug: Out of specification for assay at the 15-month test interval.
| Recall number | D-1494-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PAI Holdings, LLC. dba Pharmaceutical Associates Inc, Greenville, SC, United States |
| Recall initiated | 2020-08-04 |
| Classified | 2020-08-12 |
| Reported by FDA | 2020-08-19 |
| Terminated | 2021-09-22 |
| Distributed | Nationwide (US) |
| Quantity | 7,416 bottles |
| Reason classes | potency, specification failure |
| NDC | 00121-0810, 00121-0810-02, 00121-0810-16, 00121-4810, 00121-4810-00, 00121-4810-05, 00121-4810-40, 00121-4810-50 |
| Lot numbers | 11/20, B973 |
Product
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16
Reason for recall
Subpotent drug: Out of specification for assay at the 15-month test interval.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1494-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.