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Showing 521–540 of 2326 results

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Creamy Avocado Spicy Salsa (Pain Train) – undeclared milk (2025)

Undeclared Allergen

Undeclared Milk Allergen

Class IIModerate

FDAMay 21, 2025TX• Pain Train Salsa, LLC

Theophylline Extended-Release Tablets (Glenmark) – Dissolution Test Failure (2025)

OOS results reported for the Dissolution (by UV) test.

Class IIModerate

FDAMay 15, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Indomethacin Extended-Release Capsules (Amerisource) – Manufacturing Deviation (2025)

cGMP deviations

Class IIModerate

FDAMay 15, 2025Nationwide• Amerisource Health Services LLC

BD ChloraPrep Clear (CareFusion) – Packaging Seal Issue (2025)

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.

Class IIModerate

FDAMay 15, 2025Nationwide• CareFusion 213, LLC

Airsupra Inhalation Aerosol (AstraZeneca) – Delivery System Defect (2025)

Defective delivery system

Class IIModerate

FDAMay 14, 2025Nationwide• AsttraZeneca Pharmaceuticals LP

Dal Garlic Rice Mix (NatureMills) – Milk and Wheat (2025)

Undeclared Allergen

Undeclared milk and wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Sesame Rice Mix (NatureMills) – Undeclared Milk (2025)

Undeclared Milk

Undeclared milk

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Traditional Sambar Powder (NatureMills) – Multiple Allergens (2025)

Undeclared Allergen

Undeclared sesame and wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Idly Chili Powder (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergen

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Black Kavuni Porridge Mix (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Horsegram Rice Mix (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Moringa Leaf Soup (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Garlic Vadam (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Tomato Vadam (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Wonderberry Leaf Soup (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Avarampoo Soup (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Traditional Rasam Powder (NatureMills) – Undeclared Allergens (2025)

Undeclared Allergen

Undeclared sesame and wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Esomeprazole Magnesium Suspension 20mg (Zydus) – Impurity Specification (2025)

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

Class IIModerate

FDAMay 13, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Esomeprazole Magnesium Suspension 40mg (Zydus) – Impurity Specification (2025)

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

Class IIModerate

FDAMay 13, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Celecoxib Capsules (AvKARE) – Foreign Tablet Contamination (2025)

Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules

Class IIModerate

FDAMay 13, 2025Nationwide• AvKARE

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