Rising Pharma Holding, Inc. Recalls

All product recalls associated with Rising Pharma Holding, Inc..

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Recall Summary

Total Recalls

11

Past Year

2

Class I (Serious)

0

Most Recent

Oct 2025

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 1–11 of 11 recalls

Carbidopa Levodopa Entacapone Tablets (Rising Pharma) – Product Mix-up (2025)

Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).

Class IIModerate

FDAOct 7, 2025Nationwide• Rising Pharma Holding, Inc.

Duloxetine Capsules (Rising Pharma) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIModerate

FDAMar 5, 2025Nationwide• Rising Pharma Holding, Inc.

Duloxetine Capsules 30mg (Rising Pharma) – CGMP impurity risk (2024)

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIModerate

FDADec 30, 2024Nationwide• Rising Pharma Holding, Inc.

Duloxetine Capsules 20mg (Rising Pharma) – CGMP impurity risk (2024)

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIModerate

FDADec 30, 2024Nationwide• Rising Pharma Holding, Inc.

Duloxetine Capsules 60mg (Rising Pharma) – CGMP impurity risk (2024)

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIModerate

FDADec 30, 2024Nationwide• Rising Pharma Holding, Inc.

Duloxetine DR Capsules 30mg (Rising Pharma) – N-nitroso Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

Class IIModerate

FDANov 19, 2024Nationwide• Rising Pharma Holding, Inc.

Duloxetine DR Capsules 60mg (Rising Pharma) – N-nitroso Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

Class IIModerate

FDANov 19, 2024Nationwide• Rising Pharma Holding, Inc.

Duloxetine DR Capsules 20mg (Rising Pharma) – N-nitroso Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

Class IIModerate

FDANov 19, 2024Nationwide• Rising Pharma Holding, Inc.

Diflorasone Diacetate Ointment (Rising Pharma) – Impurity Concerns (2024)

Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.

Class IIILow

FDAJun 24, 2024Nationwide• Rising Pharma Holding, Inc.

Pregabalin Capsules (Rising Pharma) – Foreign Tablet Found (2024)

Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.

Class IIILow

FDAMay 16, 2024Nationwide• Rising Pharma Holding, Inc.

Bupropion XL Tablets (Rising Pharma) – Foreign Tablets (2023)

Presence of Foreign Tablets/Capsules

Class IIModerate

FDADec 29, 2023Nationwide• Rising Pharma Holding, Inc.

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Rising Pharma Holding, Inc. Recalls

Recall Summary

Carbidopa Levodopa Entacapone Tablets (Rising Pharma) – Product Mix-up (2025)

Duloxetine Capsules (Rising Pharma) – Nitrosamine Impurity (2025)

Duloxetine Capsules 30mg (Rising Pharma) – CGMP impurity risk (2024)

Duloxetine Capsules 20mg (Rising Pharma) – CGMP impurity risk (2024)

Duloxetine Capsules 60mg (Rising Pharma) – CGMP impurity risk (2024)

Duloxetine DR Capsules 30mg (Rising Pharma) – N-nitroso Impurity (2024)

Duloxetine DR Capsules 60mg (Rising Pharma) – N-nitroso Impurity (2024)

Duloxetine DR Capsules 20mg (Rising Pharma) – N-nitroso Impurity (2024)

Diflorasone Diacetate Ointment (Rising Pharma) – Impurity Concerns (2024)

Pregabalin Capsules (Rising Pharma) – Foreign Tablet Found (2024)

Bupropion XL Tablets (Rising Pharma) – Foreign Tablets (2023)