US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

Class I · High risk Terminated

TRESIBA FlexTouch

Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Novo Nordisk Inc NDC 0169-2550-90 D-0621-2021
Class I · High risk Terminated

Tresiba

Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Novo Nordisk Inc NDC 0169-2662-90 D-0620-2021
Class I · High risk Terminated

TRESIBA FlexTouch

Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Novo Nordisk Inc NDC 0169-2660-90 D-0619-2021
Class II · Moderate risk Terminated

Saxenda

Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Novo Nordisk Inc NDC 0169-2800-90 D-0618-2021
Class II · Moderate risk Terminated

Ozempic

Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Novo Nordisk Inc NDC 0169-4132-90 D-0617-2021
Class I · High risk Terminated

NovoLog

Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Novo Nordisk Inc NDC 0169-7501-90 D-0616-2021
Class I · High risk Terminated

NovoLog FlexPen

Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Novo Nordisk Inc NDC 0169-6339-90 D-0615-2021
Class I · High risk Terminated

Levemir FlexTouch

Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Novo Nordisk Inc NDC 0169-6438-90 D-0614-2021
Class I · High risk Terminated

Fiasp

Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Novo Nordisk Inc NDC 0169-3201-90 D-0613-2021
Class I · High risk Terminated

Fiasp PenFill

Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Novo Nordisk Inc NDC 0169-3205-91 D-0612-2021
Class I · High risk Terminated

Fiasp FlexTouch

Reason Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Novo Nordisk Inc NDC 0169-3204-90 D-0611-2021
Class III · Low risk Terminated

Candesartan Cilexetil Tablets

Reason Failed Impurities/Degradation Specifications

Macleods Pharma Usa Inc NDC 33342-114-10 D-0329-2021
Class II · Moderate risk Terminated

ChloraPrep With Tint 2% w/v chlorhexidine gluconate

Reason CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

CareFusion 213, LLC D-0350-2021
Class II · Moderate risk Terminated

ChloraPrep One-Step 2% w/v chlorhexidine gluconate

Reason CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

CareFusion 213, LLC D-0349-2021
Class II · Moderate risk Terminated

BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate

Reason Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

CareFusion 213, LLC NDC 54365-400-33 D-0348-2021
Class II · Moderate risk Terminated

BD ChloraPrep Clear

Reason Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

CareFusion 213, LLC NDC 54365-400-32 D-0347-2021
Class I · High risk Terminated

ChloraPrep With Tint 2% w/v chlorhexidine gluconate

Reason Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.

CareFusion 213, LLC D-0346-2021
Class I · High risk Terminated

ChloraPrep One-Step 2% w/v chlorhexidine gluconate

Reason Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.

CareFusion 213, LLC D-0345-2021
Class I · High risk Terminated

BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate

Reason Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.

CareFusion 213, LLC NDC 54365-400-33 D-0344-2021
Class I · High risk Terminated

BD ChloraPrep Clear

Reason Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.

CareFusion 213, LLC NDC 54365-400-32 D-0343-2021
Class III · Low risk Ongoing

Distributed by: DocRx

Reason Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.

Asclemed USA Inc. dba Enovachem Pharmaceuticals D-0330-2021
Class II · Moderate risk Terminated

Neomycin Sulfate Tablets

Reason Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay

X-Gen Pharmaceuticals Inc. NDC 39822-0310-5 D-0328-2021
Class II · Moderate risk Terminated

Omeprazole Delayed Release Capsules

Reason Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer

Golden State Medical Supply Inc. NDC 51407-129-10 D-0312-2021
Class III · Low risk Terminated

Lcl-2-0191

Reason An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.

Washington Homeopathic Products, Inc. D-0323-2021
Class III · Low risk Terminated

Sp-4

Reason An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.

Washington Homeopathic Products, Inc. D-0322-2021