FDA Drug Recalls

1,739 recalls · Class I, newest first

Class I · High risk Terminated Jul 20, 2020

OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl. Oz. (250 mL) bottle, Made in Mexico, Liq-E, S.A. DE C.V…

Reason Chemical Contamination: Products contain methanol and were below the label claim for ethanol content

Liq-E S.A. De C.V. D-0253-2021

Class I · High risk Terminated Jul 11, 2020

blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) Packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266…

Reason Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.

4e Brands North America, Llc D-0031-2021

Class I · High risk Terminated Jul 11, 2020

blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost with tea tree oil (70% ethyl alcohol), 33.8 fl oz /…

Reason Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.

4e Brands North America, Llc D-0030-2021

Class I · High risk Terminated Jul 11, 2020

blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8…

Reason Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.

4e Brands North America, Llc D-0029-2021

Class I · High risk Terminated Jul 7, 2020

Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford…

Reason Presence of Particulate Matter

Mylan Institutional LLC NDC 67457-813-50 D-1484-2020

Class I · High risk Terminated Jul 7, 2020

BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl…

Reason Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative…

CareFusion 213, LLC NDC 54365-400-33 D-0268-2021

Class I · High risk Terminated Jul 7, 2020

ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10…

Reason Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage…

CareFusion 213, LLC D-0267-2021

Class I · High risk Terminated Jul 7, 2020

ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite…

Reason Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV regions of the world where at the labeled storage…

CareFusion 213, LLC D-0266-2021

Class I · High risk Terminated Jul 7, 2020

BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3…

Reason Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative…

CareFusion 213, LLC NDC 54365-400-32 D-0265-2021

Class I · High risk Terminated Jul 2, 2020

bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation…

Reason Chemical Contamination: Product contains methanol.

AAA Cosmetica, SA de CV D-1570-2020

Class I · High risk Terminated Jul 1, 2020

Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), For Institutional and Industrial Use Only, a) foamyiQ…

Reason Microbial contamination of non-sterile products: positive microbial contamination in product.

Spartan Chemical Co Inc D-1503-2020

Class I · High risk Terminated Jun 29, 2020

Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antiseptic Hand Rub, Non-sterile Solution, Extra strength…

Reason Chemical Contamination: Presence of Undeclared Methanol

Transliquid Technologies, LLC D-1408-2020

Class I · High risk Terminated Jun 24, 2020

Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Celra…

Reason Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches

Medichem S.A. NDC 53296-0012-0 D-1534-2020

Class I · High risk Terminated Jun 23, 2020

All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%, Produced by Eskbiochem SA de CV Ave Mexico Japon 50…

Reason Chemical Contamination: Product contains undeclared methanol.

Itech 361 LLC D-1538-2020

Class I · High risk Terminated Jun 23, 2020

ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear…

Reason Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides

CareFusion 213, LLC D-1511-2020

Class I · High risk Terminated Jun 23, 2020

ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange…

Reason Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides

CareFusion 213, LLC D-1510-2020

Class I · High risk Terminated Jun 23, 2020

BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution…

Reason Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides

CareFusion 213, LLC NDC 54365-400-32 D-1509-2020

Class I · High risk Terminated Jun 22, 2020