Nystatin Oral Suspension — Class II drug recall D-0721-2021
Terminated recall by PAI Holdings, LLC. dba Pharmaceutical Associates Inc, reported 2021-08-18, distributed nationwide. Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
| Recall number | D-0721-2021 |
|---|---|
| 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 | 2021-07-29 |
| Classified | 2021-08-12 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2022-12-02 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 00121-0868, 00121-0868-00, 00121-0868-02, 00121-0868-05, 00121-0868-16, 00121-0868-40, 00121-0868-50 |
| Expiration dates | 2022-09-30, 2022-10-31 |
Product
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
Reason for recall
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
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-0721-2021. 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.