FDA Drug recall D-0154-2024
NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob…
- FDA Drug
- Class II
- ongoing
- Published 2023-12-27
On 2023-12-27 the FDA classified a Class II recall of NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob… by Fagron, citing labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0154-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-11 |
| Published | 2023-12-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fagron |
| Distribution | n/a |
Product
NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3
Reason
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Identifiers
| code_info | Lot#: 230308-U46196, Exp. date 04/30/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Fagron
- NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot K…
FDA Drug · Class II · 2023-12-27 · Fagron - NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot K…
FDA Drug · Class II · 2023-12-27 · Fagron - NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Kno…
FDA Drug · Class II · 2023-12-27 · Fagron - Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Tex…
FDA Drug · Class III · 2022-05-18 · Fagron - Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN…
FDA Drug · Class III · 2022-05-18 · Fagron
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0154-2024%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.