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Padagis US LLC

Padagis US LLC Recalls

All product recalls associated with Padagis US LLC.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Nov 2023

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–3 of 3 recalls

Trospium Chloride Capsules (Padagis) – Capsule Defects (2023)

Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules

Class IIModerate

FDANov 1, 2023Nationwide• Padagis US LLC

Gynazole-1 Vaginal Cream (Padagis) – incorrect product formulation (2023)

Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.

Class IIModerate

FDASep 28, 2023Nationwide• Padagis US LLC

Evamist (Padagis) – content uniformity failure (2023)

Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.

Class IIILow

FDAFeb 21, 2023Nationwide• Padagis US LLC