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Showing 361–380 of 2326 results

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Enoxaparin Sodium Injection (Cardinal Health) - Product Mispack (2025)

Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL

Class IIModerate

FDAAug 5, 2025KS• Cardinal Health Inc.

Frozen Half Shell Oysters (Khee Trading) – Norovirus Risk (2025)

Imported Frozen Oyster potentially contaminated with Norovirus.

Class IIModerate

FDAAug 5, 2025AZ, CA, NV +1 more• Khee Trading, Inc.

Frozen Half Shell Oysters (Khee Trading) – Norovirus Risk (2025)

Imported Frozen Oyster potentially contaminated with Norovirus.

Class IIModerate

FDAAug 5, 2025AZ, CA, NV +1 more• Khee Trading, Inc.

Baby Bedtime Drops (M.O.M Enterprises) – Yeast Contamination (2025)

Potential for spoilage due to yeast contamination.

Class IIModerate

FDAAug 5, 2025AL, AZ, AR +28 more• M.O.M Enterprises, LLC.

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.

Epinephrine Injection (Pfizer) - Sterility Issue (2025)

Lack of Assurance of Sterility.

Class IIModerate

FDAAug 4, 2025Nationwide• PFIZER INC

Lactated Ringer's Injection (B Braun) - Sterility Concern (2025)

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Class IIModerate

FDAAug 4, 2025Nationwide• B BRAUN MEDICAL INC

Potato Salad (Hans Kissle) – Undeclared Wheat (2025)

Undeclared Gluten

Contains undeclared wheat. The top label identifies the product as potato salad, but the unit contains pasta salad.

Class IIModerate

FDAAug 4, 2025CT, MA, NJ +2 more• Hans Kissle Company, LLC

Sodium Chloride Injection (B Braun) - Sterility Concern (2025)

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Class IIModerate

FDAAug 4, 2025Nationwide• B BRAUN MEDICAL INC

Sodium Bicarbonate Injection (Pfizer) - Sterility Issue (2025)

Lack of Assurance of Sterility.

Class IIModerate

FDAAug 4, 2025Nationwide• PFIZER INC

Ojasvita Chocomalt (Sri Sri Tattva) – Undeclared Soy (2025)

Product contains undeclared soy lecithin.

Class IIModerate

FDAAug 1, 2025CA, GA, IL +7 more• SRI SRI TATTVA

7up Zero Sugar Tropical Soda (Buffalo Rock) – mislabeled product (2025)

Product mislabeled - cans are labeled as Zero Sugar, but contain full sugar product

Class IIModerate

FDAJul 31, 2025AL, FL, GA• Buffalo Rock Company Inc

Frozen Oyster Meat (Jayone Foods) – Norovirus Contamination (2025)

Frozen Oyster product is potentially contaminated with Norovirus

Class IIModerate

FDAJul 31, 2025CA, IN• Jayone Foods, Inc.

Frozen Oyster Meat (Jayone Foods) – norovirus contamination (2025)

Frozen Oyster product is potentially contaminated with Norovirus

Class IIModerate

FDAJul 31, 2025CA, IN• Jayone Foods, Inc.

RECOMBINATE Antihemophilic Factor (Cardinal Health) – Temperature Deviation (2025)

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Class IIModerate

FDAJul 30, 2025Nationwide• Cardinal Health Inc.

Xolair Omalizumab Injection (Cardinal Health) – Temperature Deviation (2025)

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Class IIModerate

FDAJul 30, 2025Nationwide• Cardinal Health Inc.

Xolair Injection (Cardinal Health) - Temperature Exposure (2025)

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Class IIModerate

FDAJul 30, 2025Nationwide• Cardinal Health Inc.

Sodium Bicarbonate Injection (Exela Pharma) – Arsenic Impurities (2025)

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.

Class IIModerate

FDAJul 30, 2025Nationwide• Exela Pharma Sciences LLC

Levoxyl Levothyroxine (Pfizer) – Subpotent Drug (2025)

Subpotent drug

Class IIModerate

FDAJul 29, 2025Nationwide• Pfizer

Sucralfate Tablets (Amerisource) – Quality Monitoring Failure (2025)

CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

Class IIModerate

FDAJul 29, 2025Nationwide• Amerisource Health Services LLC

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