D-0677-2026Class II

Padagis US LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Padagis US LLC

Product type

Drug

Status

Ongoing

Report date

2026-07-22

Distribution

USA Nationwide

Firm state

Product quantity

180,936 tubes

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Validation & Qualification

Reason for recall

Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

Product description

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

Code / lot info

Lot #: 205060, Exp 09/30/2027

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See all Validation & Qualification recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →