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Showing 341–360 of 2326 results

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Frozen Shrimp in Bulk Packaging (H & N Group) – Cesium-137 risk (2025)

Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)

Class IIModerate

FDAAug 12, 2025Nationwide• H & N Group Inc.

Tavaborole Topical Solution (Viona) - Discoloration (2025)

Discoloration

Class IIModerate

FDAAug 12, 2025Nationwide• VIONA PHARMACEUTICALS INC

Graham Cracker Meal (Bakers Authority) – Undeclared allergens (2025)

Undeclared Allergen

Product label does not list ingredients including major food allergens: wheat and soy (vegetable oil). Additional undeclared ingredients include: niacin, reduced iron, vitamin B1, vitamin B2, invert sugar

Class IIModerate

FDAAug 12, 2025CA, CT, GA +14 more• Bakers Authority LLC

Lisdexamfetamine Capsules (Lannett) - Label Mix-up (2025)

Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.

Class IIModerate

FDAAug 11, 2025Nationwide• Lannett Company Inc.

Duloxetine Capsules (Breckenridge) - CGMP Impurity (2025)

CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

Class IIModerate

FDAAug 8, 2025AZ, IN, NJ• Breckenridge Pharmaceutical, Inc.

Theophylline Tablets (Glenmark) - Failed Dissolution (2025)

Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.

Class IIModerate

FDAAug 8, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 3.125mg (Glenmark) - Nitrosamine Impurity (2025)

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Class IIModerate

FDAAug 7, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 12.5mg (Glenmark) - Nitrosamine Impurity (2025)

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Class IIModerate

FDAAug 7, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Frozen Oysters (Wang Globalnet) – Norovirus contamination (2025)

Oyster product potentially contaminated with Norovirus

Class IIModerate

FDAAug 7, 2025CA, CO, MA +3 more• Wang Globalnet

Reduced Sodium Roast Beef Rub (QST Ingredients) – Metal fragment risk (2025)

Product may contain small metal fragments due to contaminated onion powder ingredient used in manufacturing.

Class IIModerate

FDAAug 7, 2025CA, IN, OR +1 more• QST Ingredients and Packaging

Cajun Seasoning (QST Ingredients) – Metal fragment risk (2025)

Product may contain small metal fragments due to contaminated onion powder ingredient used in manufacturing.

Class IIModerate

FDAAug 7, 2025CA, IN, OR +1 more• QST Ingredients and Packaging

Carvedilol Tablets 25mg (Glenmark) - Nitrosamine Impurity (2025)

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Class IIModerate

FDAAug 7, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Lemon Pepper Seasoning (QST Ingredients) – Metal fragment risk (2025)

Product may contain small metal fragments due to contaminated onion powder ingredient used in manufacturing.

Class IIModerate

FDAAug 7, 2025CA, IN, OR +1 more• QST Ingredients and Packaging

BBQ Riblet Seasoning (QST Ingredients) – Metal fragment risk (2025)

Product may contain small metal fragments due to contaminated onion powder ingredient used in manufacturing.

Class IIModerate

FDAAug 7, 2025CA, IN, OR +1 more• QST Ingredients and Packaging

Carvedilol Tablets 25mg (Glenmark) - Nitrosamine Excess (2025)

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Class IIModerate

FDAAug 6, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 12.5mg (Glenmark) - Nitrosamine Excess (2025)

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Class IIModerate

FDAAug 6, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Metoprolol Tablets 50mg (Westminster) - Nitrosamine Risk (2025)

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Class IIModerate

FDAAug 6, 2025Nationwide• Westminster Pharmaceuticals LLC

Metoprolol Tablets 100mg (Westminster) - Nitrosamine Risk (2025)

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Class IIModerate

FDAAug 6, 2025Nationwide• Westminster Pharmaceuticals LLC

Spironolactone Tablets (Sun Pharma) - Foreign Substance (2025)

Presence of foreign substance: identified as aluminum.

Class IIModerate

FDAAug 5, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Ramen Noodles (Kobayashi) – Undeclared Soy (2025)

Ramen Noodle package label does not declare Soy as the source for lecithin ingredient.

Class IIModerate

FDAAug 5, 2025CA• Kobayashi Noodle U.S.A.

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