Nystatin Oral Suspension — Class III drug recall D-0865-2018
Terminated recall by Pharmaceutical Associates Inc, reported 2018-06-13, distributed nationwide. Resuspension problems: Out of specification for appearance and resuspendability.
| Recall number | D-0865-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmaceutical Associates Inc, Greenville, SC, United States |
| Recall initiated | 2018-05-29 |
| Classified | 2018-06-13 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2020-01-13 |
| Distributed | Nationwide (US) |
| Quantity | 275,400 cups |
| Reason classes | 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 | B5B8 |
| Expiration dates | 2019-07 |
Product
Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05
Reason for recall
Resuspension problems: Out of specification for appearance and resuspendability.
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-0865-2018. 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.