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
Carefusion 213, Llc
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ...
Drugs·14,275,400 affected·Mar 19, 2021
High RiskFDA
Ultratab Laboratories, Inc.
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00
Drugs·14,066,434 affected·Jan 26, 2022
High RiskFDA
Baxter Healthcare Corporation
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Medical Devices·14,053,824 affected·Nov 23, 2022
CriticalFDA
Biomerieux, Inc.
bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card ...
Diagnostic Devices·13,961,320 affected·Jan 26, 2018
High RiskFDA
Hospira Inc.
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- ...
Drugs·13,720,475 affected·Jan 23, 2015
CriticalFDA
Blue Bell Creameries, L.p.
Blue Bell Ice Cream Dutch Chocolate One Pint (473mL) and Half Pint Size
Dairy·13,701,935 affected·Mar 13, 2015
High RiskFDA
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 20ML L/L Model/Catalog Number: 83088 Product Description: NON-Sterile syringes without needles f...
Medical Devices·13,574,000 affected·Apr 5, 2024
High RiskFDA
Lloyd Inc. Of Iowa
Lloyd Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the l...
Oral Drugs·13,460,920 affected·Apr 1, 2013
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usa...
Diagnostic Devices·13,064,500 affected·Mar 16, 2017
High RiskFDA
Hospira Inc.
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- ...
Drugs·12,460,975 affected·Jun 30, 2015
High RiskFDA
Medtronic Minimed Inc.
Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-37...
Diabetes Devices·12,400,098 affected·Nov 4, 2014
High RiskFDA
Sunset Natural Products Inc.
Aloe Vera 500 mg, bulk capsules
Food·12,310,000 affected·Oct 13, 2015
High RiskFDA
B Braun Medical Inc
Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, ...
Medical Devices·12,225,913 affected·Oct 29, 2025
CriticalFDA
Blue Bell Creameries, L.p.
Blue Bell Buttered Pecan One Pint (473 mL)
Dairy·12,034,950 affected·Mar 13, 2015
High RiskFDA
Novartis Consumer Health
Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufactured by Novartis Consumer Health, Inc, Lincoln, NE / There ...
Oral Drugs·11,846,608 affected·Sep 3, 2013
High RiskFDA
Sunopta Grains And Foods Inc.
Kirkland Signature Organic Soy Non-Dairy Beverage Vanilla; 12- 32 oz. cartons (note- 12 count consumer display case) SunOpta Item num...
Dairy·11,821,341 affected·Jan 26, 2022
High RiskFDA
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product Description: NON-Sterile syringes without needles fo...
Medical Devices·11,584,000 affected·Apr 5, 2024
High RiskFDA
Granules Usa, Inc.
Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Villa...
Oral Drugs·11,450,000 affected·Aug 11, 2021
CriticalFDA
Blue Bell Creameries, L.p.
Blue Bell Ice Cream Cookies 'n Cream Still a 1/2 Gal (2 QTS)
Dairy·11,405,629 affected·Mar 13, 2015
High RiskFDA
Ultra Seal Corporation
Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets, Manufactur...
Oral Drugs·11,401,641 affected·Jan 24, 2022
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 50...
Medical Devices·11,389,800 affected·Sep 18, 2019
CriticalFDA
Frito-lay, Inc
20 count Frito-Lay Bold Mix Sack 18.4 oz. packaged in flexible plastic
Food·11,342,163 affected·Apr 21, 2017
High RiskFDA
Medline Industries, Lp
Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS
Medical Devices·11,291,800 affected·Oct 27, 2025
High RiskFDA
Smiths Medical Asd Inc.
CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (exc...
Medical Devices·11,170,535 affected·Sep 25, 2017
CriticalFDA
Carefusion 213, Llc
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3...
Drugs·11,115,774 affected·Mar 19, 2021
CriticalFDA
Crf Frozen Foods, Llc
Organic Mixed Vegetables with Shelled Edamame, brand Bybee Foods, frozen, net wt. 5lb. UPC 4635800001 Organic Vegetable Medley, brand ...
Produce·11,051,858 affected·May 2, 2016
CriticalFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.
Diabetes Devices·11,000,000 affected·Jun 7, 2013
High RiskFDA
C.r. Bard, Inc.
Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbe...
Surgical Devices·10,949,013 affected·Sep 14, 2017
High RiskFDA
B Braun Medical Inc
SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model...
Medical Devices·10,658,351 affected·Aug 15, 2024
High RiskFDA
Novartis Consumer Health
Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed ...
Oral Drugs·10,624,000 affected·Jun 6, 2013
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 0690...
Diabetes Devices·10,546,420 affected·Jul 28, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Diagnostic Devices·10,310,443 affected·Feb 21, 2018
CriticalFDA
Standard Homeopathic Company
Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.00000000000...
Oral Drugs·10,263,585 affected·Apr 13, 2017
High RiskFDA
3m Company - Health Care Business
3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50...
Medical Devices·10,145,050 affected·Sep 15, 2020
High RiskFDA
Vi-jon, Llc
Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 FL OZ (296 mL), a) Best Choice UPC 0 70038 58790 3 Proudly ...
Oral Drugs·10,070,526 affected·Jul 15, 2022
High RiskFDA
Innovagel
Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186...
Oral Drugs·9,992,768 affected·Jan 5, 2017
High RiskFDA
Treehouse Foods
GOOD & GATHER 12/9oz GRDL WFL MINI HSTYLE ORG-GDGTR UPC 085239343029 H-E-B 12/9oz GRDL WFL MINI HSTYLE ORG-HEBUT UPC 041220708413 365 ORG...
Food·9,907,389 affected·Oct 17, 2024
High RiskFDA
Treehouse Foods
BREAKFAST BEST 8/33oz GRDL PNCK BDAY-BKBST UPC 4061459959116
Food·9,907,389 affected·Oct 17, 2024
High RiskFDA
Treehouse Foods
SIGNATURE SELECT 12/14.1oz GRDL PNCK MINI-SIGSL UPC 021130095889
Food·9,907,389 affected·Oct 17, 2024
High RiskFDA
Treehouse Foods
H-E-B HIGHER HARVEST 12/10.72oz GRDL WFL BLBRY PRTN-HEBHH UPC 041220708093 BETTERGOODS 12/10.72oz GRDL WFL BLBRY PRTN-BTRGD UPC 194346252...
Food·9,907,389 affected·Oct 17, 2024
High RiskFDA
Treehouse Foods
NATURES PATH ORGANIC 12/7.4oz GRDL WFL CHIA ORG GF-NPTHO UPC 058449590729 NATURES PATH ORGANIC 12/210g GRDL WFL CHIA ORG GF-NPOCN UPC 058...
Food·9,907,389 affected·Oct 17, 2024
High RiskFDA
Treehouse Foods
GOOD & GATHER 12/9oz GRDL WFL MINI BLBRY ORG-GDGTR UPC 085239343012 365 ORGANIC 12/9oz GRDL WFL MINI BLBRY ORG - 365OR UPC 099482437008
Food·9,907,389 affected·Oct 17, 2024
High RiskFDA
Treehouse Foods
GIANT EAGLE 12/11.3oz GRDL WFL BCKWHE BLBRY GF-GT/EG UPC 030034944940 H-E-B HIGHER HARVEST 12/11.3oz GRDL WFL BCKWHE BLBRY GF-HEBHH UPC 0...
Food·9,907,389 affected·Oct 17, 2024
High RiskFDA
Treehouse Foods
WEGMANS 12/16.5oz GRDL PNCK BB-WEGMN UPC 077890481387 YELLOH 12/16.5oz GRDL PNCK BLBRY-YLLOH UPC 810038684680 GIANT EAGLE 12/16.5oz GRDL ...
Food·9,907,389 affected·Oct 17, 2024
High RiskFDA
Treehouse Foods
WESTERN FAMILY 12/280g GRDL WFL CIN - WSTCN UPC 062639310134 GREAT VALUE 12/280g GRDL WFL CIN - GRVLC UPC 681131811712 SELECTION 12/280g ...
Food·9,907,389 affected·Oct 17, 2024
High RiskFDA
Treehouse Foods
KRUSTEAZ 1/2.5lb GRDL WFL BLGN 7-KRSTZ UPC 068615115168 KRUSTEAZ 1/11.25oz GRDL WFL BLGN-KRSTZ UPC BAKERS SOURCE 1/11.25oz GRDL WFL BLGN...
Food·9,907,389 affected·Oct 17, 2024
High RiskFDA
Treehouse Foods
SIMPLE TRUTH 12/11.3oz GRDL WFL BLBRY GF-SMPTR UPC 011110105509
Food·9,907,389 affected·Oct 17, 2024
High RiskFDA
Treehouse Foods
KODIAK CAKES 8/14.8oz GRDL WFL BLGN BLBRY-KDKCS UPC 705599014826
Bakery & Grains·9,907,389 affected·Oct 17, 2024