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
CriticalFDA
Lyons Magnus, Inc
Chocolate Syrup, MIDRWB36XX. Item 10137 Ingredients: water, cocoa (processed with alkali), cane sugar. Net: 235 gal (889.6L) Lyons...
Snacks & Candy·53,818,025 affected·Jul 22, 2022
CriticalFDA
Lyons Magnus, Inc
Lyons Ready Care No Sugar Added 1.7 high Calorie High Protein Nutritional Drink Vanilla. 32 fl oz. (1QT) 946mL. UPC 0 45796-10047 3. ...
Beverages·53,818,025 affected·Jul 22, 2022
CriticalFDA
Lyons Magnus, Inc
Optimum Nutrition Gold Standard 100% Whey Chocolate 11 fl oz (325mL). UPC 7 48927-06409 4. Shake well. Best when served chilled. Ma...
Snacks & Candy·53,818,025 affected·Jul 22, 2022
CriticalFDA
Lyons Magnus, Inc
Abbott PediaSure Harvest 1.0 Cal, For Tube Feeding. Complete nutrition blend. 8 fl oz (237mL). UPC 0 70074-67963 1. 24 count case UP...
Food·53,818,025 affected·Jul 22, 2022
CriticalFDA
Lyons Magnus, Inc
Tone It Up Plant-Based Protein Shake Chocolate. 11 fl oz (325mL). UPC 8 10745-03194 4. Sold in 4-count wrap UPC 810745031869. Shake...
Snacks & Candy·53,818,025 affected·Jul 22, 2022
CriticalFDA
Lyons Magnus, Inc
Lyons Ready Care 2.0 Chocolate High Calorie, High Protein, Nutritional Drink. 32 FL OZ (1 QT) 946mL UPC 0 45796-10050 3 Item 10050....
Snacks & Candy·53,818,025 affected·Jul 22, 2022
CriticalFDA
Lyons Magnus, Inc
pirq Plant Protein Super Foods, Golden Vanilla Drink, Almonds, Curcumin, Maca. 11 FL OZ (325ML). UPC 8 57690-00804 1. Packaged in t...
Beverages·53,818,025 affected·Jul 22, 2022
CriticalFDA
Lyons Magnus, Inc
Glucerna original Rich Chocolate Shake, 8 FL OZ (237 mL). Delicious Snack or Small Meal Replacement. UPC 0 70074-68565 6. Sold in 24...
Snacks & Candy·53,818,025 affected·Jul 22, 2022
CriticalFDA
Lyons Magnus, Inc
Sysco Imperial Med Plus NSA 1.7 Vanilla Nutritional Drink. High Calorie, High Protein. Mildly Thick Nectar Consistency. 32 FL OZ (1...
Beverages·53,818,025 affected·Jul 22, 2022
CriticalFDA
Lyons Magnus, Inc
pirq Plant Protein Super Foods, Decadent Chocolate Drink, Almonds, Curcumin, Maca. 11 FL OZ (325ML). UPC 8 57690-00806 5. Packaged ...
Snacks & Candy·53,818,025 affected·Jul 22, 2022
CriticalFDA
Lyons Magnus, Inc
Premier Protein Cafe Latte High protein shake. 11 FL OZ (325mL). Packaged in the following configurations: 1. Carton UPC 6 4384...
Food·53,818,025 affected·Jul 22, 2022
CriticalFDA
Lyons Magnus, Inc
Glucerna original Creamy Strawberry Shake, 8 FL OZ (237 mL). Delicious Snack or Small Meal Replacement. UPC 0 70074-68567 0. Sold as...
Snacks & Candy·53,818,025 affected·Jul 22, 2022
CriticalFDA
Lyons Magnus, Inc
Optimum Nutrition Gold Standard 100% Whey Vanilla 11 fl oz (325mL). UPC 7 48927-06410 0. Shake well. Best when served chilled. Manu...
Food·53,818,025 affected·Jul 22, 2022
CriticalFDA
Lyons Magnus, Inc
Organic Valley Organic 1% Milkfat Lowfat Milk. 8 fl oz UPC 0 93966-00837 1. 12 Count wrap UPC 00093966008524. Chill and Shake before...
Dairy·53,818,025 affected·Jul 22, 2022
High RiskFDA
Marksans Pharma Inc.
Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured ...
Oral Drugs·52,549,000 affected·Jan 9, 2018
High RiskFDA
Nestle Infant Nutrition
GERBER Organic 2ND FOODS¿ Carrots, Apples & Mangoes, 3.5 oz., film pouches, 6 pouches per display box/ 2 display boxes per case, 9Pc Ass...
Food·51,955,335 affected·Mar 24, 2016
High RiskFDA
Nestle Infant Nutrition
GERBER Organic 2ND FOODS Pears, Carrots & Peas, 3.5 oz., film pouches, 6 pouches per display box/ 2 display boxes per case; Asst Ecom PK...
Food·51,945,335 affected·Mar 24, 2016
High RiskFDA
Ultratab Laboratories, Inc.
HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Hig...
Oral Drugs·50,585,623 affected·Jan 26, 2022
CriticalFDA
Blue Bell Creameries, L.p.
Blue Bell Ice Cream The Original Homemade Vanilla Flavored Natural and Artificial Flavor Added Still a 1/2 Gal (2 QTS)
Dairy·49,899,313 affected·Mar 13, 2015
High RiskFDA
B Braun Medical Inc
Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,...
Medical Devices·49,330,370 affected·Oct 29, 2025
CriticalFDA
Smiths Medical Asd Inc.
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24...
Medical Devices·47,595,495 affected·Dec 9, 2022
High RiskFDA
Tripath Imaging, Inc.
PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
Diagnostic Devices·46,112,784 affected·Mar 22, 2012
High RiskFDA
Tripath Imaging, Inc.
PrepStain Syringing Pipettes 240 (Catalog #490517)
Medical Devices·46,112,784 affected·Mar 22, 2012
High RiskFDA
Tripath Imaging, Inc.
PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syr...
Medical Devices·46,112,784 affected·Mar 22, 2012
CriticalFDA
Smiths Medical Asd Inc.
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, ...
Medical Devices·45,285,351 affected·Dec 9, 2022
High RiskFDA
Ultra Seal Corporation
Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,...
Oral Drugs·42,394,018 affected·Oct 13, 2021
High RiskFDA
Ultratab Laboratories, Inc.
MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY
Supplements·42,352,387 affected·Oct 6, 2021
High RiskFDA
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·40,720,900 affected·Mar 19, 2021
High RiskFDA
Cargill, Inc Corporate Headquarters
PROLIA SOY FLR 200/20 STD BLK, PROLIA SOY FLR 200/70 STD BLK, PROLIA SOY FLR 300/70 NT BLK, PROLIA SOY FLR 100/20 STD 1MT TT, PROLIA SOY ...
Food·40,536,866 affected·Mar 30, 2023
High RiskFDA
Ultratab Laboratories, Inc.
Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00
Oral Drugs·37,464,418 affected·Jan 26, 2022
CriticalFDA
Frito-lay, Inc
Jalape¿o Flavored Lays Kettle Cooked potato chips and Jalape¿o Flavored Miss Vickies Kettle Cooked potato chips in the following unit siz...
Snacks & Candy·36,761,818 affected·Apr 21, 2017
CriticalFDA
Crf Frozen Foods, Llc
Green Peas, Brand Bybee's Best, Net Wt 20 lb, UPC 4635800011 Green Peas, Brand Byee Foods, Net Wt 50 lb, UPC 155000007785CR Organic Swe...
Frozen Food·36,178,713 affected·May 2, 2016
High RiskFDA
Baxter Healthcare Corporation
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
Medical Devices·33,866,400 affected·Feb 1, 2023
CriticalFDA
B. Braun Medical, Inc.
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/...
Medical Devices·33,820,976 affected·Nov 1, 2023
CriticalFDA
Crf Frozen Foods, Llc
Cut Green Beans, Brand Bybee Foods, Net Wt 50 lb, UPC 205050004485CR Organic Petite Whole Green Beans, Brand Bybee Foods, Net Wt 5 lb, U...
Food·33,759,454 affected·May 2, 2016
High RiskFDA
Ultratab Laboratories, Inc.
3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., High...
Drugs·33,758,436 affected·Jan 26, 2022
High RiskFDA
Huons Co., Ltd.
Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do,...
Injectable Drugs·33,599,925 affected·Apr 2, 2026
CriticalFDA
Carefusion 303, Inc.
BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS C...
Medical Devices·33,162,680 affected·Jul 8, 2025
CriticalFDA
Crf Frozen Foods, Llc
Cut Corn, Brand Bybee's Best, Net Wt 20 lb, UPC 4635800010 Cut Corn, Brand Bybee's Best, Net Wt 55 lb, UPC 45720025 Cut Corn, Brand Byb...
Food·32,186,790 affected·May 2, 2016
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Urine Collection Cups, Cat. No. 364941
Medical Devices·29,982,150 affected·Aug 30, 2018
High RiskFDA
Becton Dickinson & Company
KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens
Medical Devices·29,982,150 affected·Aug 30, 2018
High RiskFDA
Becton Dickinson & Company
KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis
Medical Devices·29,982,150 affected·Aug 30, 2018
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD...
Medical Devices·29,815,600 affected·Dec 3, 2015
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD...
Medical Devices·29,815,600 affected·Dec 3, 2015
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD,...
Medical Devices·29,815,600 affected·Dec 3, 2015
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, ...
Medical Devices·29,815,600 affected·Dec 3, 2015
High RiskFDA
Cardinal Health 200, Llc
Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal ba...
Medical Devices·29,810,665 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal...
Medical Devices·29,810,665 affected·Jan 7, 2021