Padagis US LLC

Complete recall history across all FDA and CPSC categories — 7 total recalls

Padagis US LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (7)

FDA drug safety enforcement actions by Padagis US LLC

Date Product Reason Class
Feb 6, 2025 Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical U... Defective Container: Some packets may not be fully sealed, potentially allowi... Class II
Oct 11, 2024 Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Man... Subpotent and Superpotent Drug. Out of specification assay results recorded a... Class III
Nov 1, 2023 Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, R... Failed Tablets/Capsules specifications; missing/broken/extra tablets within t... Class II
Sep 28, 2023 Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pr... Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manuf... Class II
Feb 21, 2023 Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 f... Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) ... Class III
Aug 17, 2022 Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By ... CGMP Deviations: Product complaints reporting the product to have a gritty te... Class II
Dec 27, 2021 Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bott... Defective Delivery System Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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