Insights

Largest Product Recalls

The biggest product recalls on record by total units affected. Sorted from largest to smallest across CPSC, FDA, and USDA datasets.

480 recalls
High RiskFDA
Synthes (usa) Products Llc
3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone Product Usage: Intended for...
Medical Devices·19,497,844 affected·Feb 16, 2016
High RiskFDA
Sunset Natural Products Inc.
Colon Therapy, bulk capsules
Food·19,455,300 affected·Oct 13, 2015
High RiskFDA
Unichem Pharmaceuticals Usa Inc
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind. Estate, Pi...
Oral Drugs·19,161,600 affected·Jan 29, 2020
High RiskFDA
Ultratab Laboratories, Inc.
4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAt...
Drugs·19,103,287 affected·Jan 26, 2022
High RiskFDA
Ultratab Laboratories, Inc.
APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00
Drugs·18,772,640 affected·Jan 26, 2022
CriticalFDA
Coopersurgical, Inc.
MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Dispos...
Medical Devices·18,696,754 affected·Jan 26, 2015
CriticalFDA
Blue Bell Creameries, L.p.
12 Pak Dutch Chocolate and Homemade Vanilla Cups; 12 Pak Homemade Vanilla Cups; DZ Homemade Vanilla Cups - Single Serve Snack Item
Snacks & Candy·18,633,232 affected·Mar 13, 2015
High RiskFDA
Beyond White Spa Llc D.b.a. Ezywipe Of Amercia
Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.
Medical Devices·18,500,000 affected·Jul 21, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Stay Safe Cap
Medical Devices·18,236,160 affected·Oct 10, 2023
High RiskFDA
4e Brands North America, Llc
Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier Inte...
Supplements·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49069 8 b) 10...
Supplements·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 ...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49070 4 b) ...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4 b...
Drugs·17,359,247 affected·Jul 11, 2020
CriticalFDA
4e Brands North America, Llc
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 ...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL bottle, Distributed in USA and Canada...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl...
Drugs·17,359,247 affected·Jul 11, 2020
CriticalFDA
4e Brands North America, Llc
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 02359 4...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
Medique Products
Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets per Unit Dose Packe...
Oral Drugs·16,630,118 affected·Dec 6, 2021
CriticalFDA
Confections By Michael Recchiuti
Recchiuti Feve. Net Wt. 3 oz. (85 G) Ingredient: Dark chocolate {cocoa beans, sugar, cocoa butter, soy lecithin (emulsifier)} Nat...
Dairy·16,518,000 affected·Nov 9, 2018
High RiskFDA
Hospira Inc.
0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
Injectable Drugs·16,487,040 affected·Oct 14, 2014
High RiskFDA
Ultratab Laboratories, Inc.
Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00
Drugs·16,429,211 affected·Jan 26, 2022
High RiskFDA
Becton Dickinson & Company
BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
Medical Devices·16,099,310 affected·Apr 16, 2020
High RiskFDA
Abbott Laboratories
Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
Food·15,865,104 affected·Oct 13, 2022
High RiskFDA
Teleflex Medical
AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile w...
Medical Devices·15,779,607 affected·Jan 14, 2015
High RiskFDA
Teleflex Medical
AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile w...
Medical Devices·15,779,607 affected·Jan 14, 2015
High RiskFDA
Teleflex Medical
AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is an accessory which allows connection of steril...
Medical Devices·15,779,607 affected·Jan 14, 2015
High RiskFDA
Teleflex Medical
AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or ste...
Medical Devices·15,779,607 affected·Jan 14, 2015
High RiskFDA
Teleflex Medical
AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile wa...
Medical Devices·15,779,607 affected·Jan 14, 2015
High RiskFDA
Teleflex Medical
ADAPTOR, 040 HUM, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile sal...
Medical Devices·15,779,607 affected·Jan 14, 2015
High RiskFDA
Teleflex Medical
AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile wa...
Medical Devices·15,779,607 affected·Jan 14, 2015
High RiskFDA
Teleflex Medical
AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile w...
Medical Devices·15,779,607 affected·Jan 14, 2015
High RiskFDA
Boehringer Ingelheim Roxane Inc
SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 3...
Oral Drugs·15,385,232 affected·Aug 30, 2013
High RiskFDA
Hospira A Pfizer Company
Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: ...
Injectable Drugs·15,034,600 affected·Jun 15, 2017
High RiskFDA
Medline Industries, Lp
Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: ...
Surgical Devices·14,927,765 affected·Jan 7, 2026
High RiskFDA
Icu Medical, Inc.
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Medical Devices·14,684,607 affected·Dec 19, 2025
High RiskFDA
Abbott Laboratories
Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count case
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Beverages·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Ultratab Laboratories, Inc.
Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., High...
Oral Drugs·14,566,510 affected·Jan 26, 2022
High RiskFDA
Ultratab Laboratories, Inc.
APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY...
Oral Drugs·14,349,148 affected·Jan 26, 2022