FDA Drug recall D-0721-2021
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
- FDA Drug
- Class II
- terminated
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of 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 by Pai Holdings, citing lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0721-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-29 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pai Holdings |
| Distribution | US |
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
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Identifiers
| ndc | 0121-0868-02 |
|---|---|
| ndc | 0121-0868-16 |
| ndc | 0121-0868-05 |
| ndc | 0121-0868-40 |
| ndc | 0121-0868-50 |
| ndc | 0121-0868-00 |
| code_info | Lots: a) C98F, C990 Exp. 30SEP2022, C9C2 Exp. 31OCT2022; b) C9E1 Exp. 31OCT2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0721-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.