FDA Drug recall D-0677-2026
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-…
- FDA Drug
- Class II
- ongoing
- Published 2026-07-22
On 2026-07-22 the FDA classified a Class II recall of Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-… by Padagis Us, citing subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0677-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-23 |
| Published | 2026-07-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Padagis Us |
| Distribution | US |
Product
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35
Reason
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Identifiers
| ndc | 45802-059-35 |
|---|---|
| ndc | 45802-059-11 |
| code_info | Lot #: 205060, Exp 09/30/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2023-11-08 · Padagis Us - Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by…
FDA Drug · Class III · 2023-03-22 · Padagis Us
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0677-2026%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.