Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

98 recalls · Class I, newest first

Class I · High risk

Easy Care First Aid 10 Person 2009 ANSI

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

Terminated Microbial contamination GFA Production Xiamen Co. Ltd. D-0253-2023
Class I · High risk

CVS First Aid Home

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

Terminated Microbial contamination GFA Production Xiamen Co. Ltd. D-0252-2023
Class I · High risk

Easy Care First Aid 25 Person 2009 ANSI

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

Terminated Microbial contamination GFA Production Xiamen Co. Ltd. D-0251-2023
Class I · High risk

Easy Care First Aid 10 Person 2009 ANSI

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

Terminated Microbial contamination GFA Production Xiamen Co. Ltd. D-0249-2023
Class I · High risk

Easy Care First Aid 25 Person 2009 ANSI

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

Terminated Microbial contamination GFA Production Xiamen Co. Ltd. D-0248-2023
Class I · High risk

Adventure First Aid 1.5

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

Terminated Microbial contamination GFA Production Xiamen Co. Ltd. D-0247-2023
Class I · High risk

Adventure First Aid 1.0

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

Terminated Microbial contamination GFA Production Xiamen Co. Ltd. D-0246-2023
Class I · High risk

Adventure Marine 150

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

Terminated Microbial contamination GFA Production Xiamen Co. Ltd. D-0245-2023
Class I · High risk

Easy Care first aid Burn Cream

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

Terminated Microbial contamination GFA Production Xiamen Co. Ltd. D-0244-2023
Class I · High risk

Epinephrine

Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product

Terminated Failed specification Spectrum Laboratory Products, Inc. D-0180-2023
Class I · High risk

Epinephrine

Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product

Terminated Failed specification Spectrum Laboratory Products, Inc. D-0179-2023
Class I · High risk

Advil Liqui Gels

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

Terminated Labeling / mix-up Glaxosmithkline Consumer Healthcare Holdings DBA Haleon D-0183-2023
Class I · High risk

Advil Liqui Gels

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

Terminated Labeling / mix-up Glaxosmithkline Consumer Healthcare Holdings DBA Haleon D-0182-2023
Class I · High risk

Advil (ibuprofen)

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

Terminated Labeling / mix-up Glaxosmithkline Consumer Healthcare Holdings DBA Haleon D-0181-2023
Class I · High risk

Iohexol (300 mg Iodine/mL)

Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL

Terminated Labeling / mix-up BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy D-0086-2023
Class I · High risk

8.4% Sodium Bicarbonate Injection

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

Terminated Packaging defect Exela Pharma Sciences LLC NDC 72572-740-20 D-0080-2023
Class I · High risk

8.4% Sodium Bicarbonate Injection

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

Terminated Packaging defect Exela Pharma Sciences LLC NDC 51754-5001-5 D-0079-2023
Class I · High risk

8.4% Sodium Bicarbonate Injection

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

Terminated Packaging defect Exela Pharma Sciences LLC NDC 72572-740-20 D-0023-2023
Class I · High risk

8.4% Sodium Bicarbonate Injection

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

Terminated Packaging defect Exela Pharma Sciences LLC NDC 51754-5001-5 D-0022-2023
Class I · High risk

Atenolol Tablets

Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets

Terminated Labeling / mix-up Golden State Medical Supply Inc. NDC 60429-027-10 D-0019-2023

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