Severity 5 of 5

Critical recalls

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

What “critical” means here

Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

451–475 of 592

CriticalFDA (Food)·F-1636-2022·2022-09-07
Lactation Smoothie Recalled Nationwide Due to Bacterial Contamination
Sweetie Pie Organics Lactation Smoothie is recalled nationwide due to contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume affected products.
Product
Sweetie Pie Organics Lactation Smoothie Apple Pear. 11.1 FL OZ (330 mL) UPC 8 56334-00254 4. No. 975001. Packaged in the following configurations: 1. 12 count case 2. 4 count wrap UPC 856334002575. Refrigerate after opening and consume within 24 hours. Distri
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1611-2022·2022-09-07
Lyons Ready Care 2.0 Chocolate Drink Recalled for Potential Bacterial Contamination
Lyons Magnus recalls Lyons Ready Care 2.0 Chocolate Nutritional Drink nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected units have lot codes 8212 and 9302.
Product
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. 12 count case UPC 10045796100500. Refrigerate after opening. Lyons Magnus, Fresno, CA 93702.
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1585-2022·2022-09-07
IQF Frozen Dill Recalled for Listeria Monocytogenes Contamination
Supherb Farms is recalling IQF Fresh Frozen Dill nationwide and in Canada after testing detected Listeria Monocytogenes in the product. The recall affects approximately 25,009 pounds distributed in 35-pound bulk cases.
Product
IQF Fresh Frozen Dill shipped in 35 lb. cases in bulk. Supherb Farms Turlock, CA Perishable, Keep Frozen
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1634-2022·2022-09-07
Nutritional Drink Recalled for Potential Cronobacter and Botulinum Contamination
Sysco Imperial Med Plus 2.0 nutritional drink is recalled nationwide for potential contamination with Cronobacter sakazakii and Clostridium botulinum. The FDA classified this as Class I.
Product
Sysco Imperial Med Plus 2.0 butter Pecan Nutritional Drink. High Calorie, High Protein. Mildly Thick Nectar Consistency. 32 FL OZ (1 QT) 946mL UPC 0 74865-92732 1. Reorder # 0108936. 12 count case UPC 10074865927328. Refrigerate prior to serving. Shake well. Ref
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1624-2022·2022-09-07
Premier Protein Vanilla Shake recalled for bacterial contamination
Premier Protein Vanilla High Protein Shake is recalled due to findings and potential for Cronobacter sakazakii and Clostridium botulinum in a nationwide distribution of 53,818,025 units.
Product
Premier Protein Vanilla High protein shake. 11 FL OZ (325mL). Packaged in the following configurations: 1. Carton UPC 6 43843-71535 1 packed in 18 count case UPC 643843718642. 2. Carton UPC 6 43843-71450 7 packed in 12 count case UPC 643843713944. 3. Carton UPC
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1635-2022·2022-09-07
Lactation Smoothie Recalled Nationwide for Potential Bacterial Contamination
Sweetie Pie Organics Lactation Smoothie Mango Banana is recalled due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The recall affects 53,818,025 units distributed nationwide.
Product
Sweetie Pie Organics Lactation Smoothie Mango Banana. 32 FL OZ (1 QT) 946mL UPC 8 56334-00278 0. No. 955001. Packaged in the following configurations: 1. 12 count case 2. 4 count wrap UPC 856334002810. Refrigerate after opening and consume within 24 hours. Distr
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1644-2022·2022-09-07
Stumptown Cold Brew Coffee Recalled for Cronobacter and Botulism Risk
Stumptown Cold Brew Coffee with Oatmilk Original is recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. This FDA Class I recall affects approximately 53.8 million units.
Product
Stumptown Cold Brew Coffee with Oatmilk Original. Made with Oatly! Low Sugar. 11 Fl Oz. 325 ML. UPC 8 55186-00687 8. Sold in 12-count case UPC 108551860006844. Manufactured for Stumptown Coffee Roasters, 100 SE Salmon St. Portland, OR 97214
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1648-2022·2022-09-07
Lyons Plant-Based Protein Shake Recalled for Bacterial Contamination
Lyons Magnus is recalling Lyons Ready Care Plant-Based Protein Shake Chocolate nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum, serious bacterial pathogens that can cause illness.
Product
Lyons Ready Care Plant-Based Protein Shake Chocolate. 8.45 fl oz. (250mL) UPC 0 45796-10081 7. Mildly Thick Nectar Consistency. Refrigerate prior to serving. Shake Well. Sold in 24-count case UPC 10045796100814. Lyons Magnus, Fresno, CA 93702.
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1621-2022·2022-09-07
Plant Protein Drink Recalled for Bacterial Contamination
Lyons Magnus is recalling pirq Plant Protein Super Foods Very Strawberry Drink nationwide due to findings of Cronobacter sakazakii and Clostridium botulinum. Approximately 53.8 million units are affected in this Class I recall.
Product
pirq Plant Protein Super Foods, Very Strawberry Drink, Almonds, Curcumin, Maca. 11 FL OZ (325ML). UPC 8 57690-00830 0. Packaged in the following configurations: 1. 12 count case UPC 857690008331. 2. 4 count wrap UPC 857690008317. Chill it, Shake it. Do not Fr
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1522-2022·2022-08-31
INTERA 3000 implantable pump recalled for higher-than-expected flow rate
The FDA is recalling INTERA 3000 implantable hepatic infusion pumps due to a malfunction causing higher-than-expected medication flow rates. Patients should contact their healthcare provider.
Product
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Category
Medical Device
Distribution
13 states
CriticalFDA (Food)·F-1596-2022·2022-08-24
Kingdom Creamery 8.5% Gelato Mix Products Recalled for Potential Listeria Contamination
Kingdom Creamery of Vermont is recalling 8.5% Gelato Mix due to potential Listeria monocytogenes contamination. The recall involves 1,623 cases distributed in Vermont, Maine, and Massachusetts.
Product
SOCO 8.5% Gelato Mix; 8.5% Gelato Mix; both labels list Kingdom Creamery of Vermont
Category
Food
Distribution
3 states
CriticalFDA (Drugs)·D-1342-2022·2022-08-24
Hand sanitizer recalled for methanol contamination and insufficient ethanol
Medek LLC is recalling M Hand Sanitizer due to FDA analysis finding methanol contamination and ethanol levels below label claims. Approximately 256 bottles distributed in Texas.
Product
M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kosas S.A. de C.V. Puebla 105 Col. Rodriguez Reynosa, Tam, Mexico C.P. 88630, NDC Code: 77797-001-01, Distributed by: Medek, LLC 315 E. Business Hwy 83 Alamo, TX
Category
Drug
Distribution
0 states
CriticalCPSC·22200·2022-08-15
4moms MamaRoo and RockaRoo Baby Swings and Rockers Strangulation Hazard
4moms is recalling over 2 million MamaRoo baby swings and 220,000 RockaRoo rockers because dangling restraint straps pose a strangulation hazard to crawling infants. One death has been reported.
Product
4moms MamaRoo Baby Swing, versions 1.0 through 4.0 and RockaRoo Baby Rockers
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1513-2022·2022-08-10
Pecan Deluxe Candy Double Fudge Blend recalled for undeclared peanut allergen
Pecan Deluxe Candy Company is recalling Double Fudge Blend candy due to potential undeclared peanut content, which poses a risk to consumers with peanut allergies.
Product
Double Fudge Blend (04-3118-35) 35lbs. (15.88 KG) packaged in a blue plastic bag (ZZ500) inside a printed corrugated box (ZZ240),
Category
Food
Distribution
1 state
CriticalFDA (Drugs)·D-1292-2022·2022-08-03
Insulin Glargine Prefilled Pens Recalled for Missing Label
Mylan Pharmaceuticals is recalling Insulin Glargine prefilled pens (lot BF21002895) distributed nationwide because some pens lack labels, which could prevent patients from properly identifying and administering the medication.
Product
Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specia
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1188-2022·2022-07-20
Morphine Sulfate Extended-Release Tablets Recalled for Strength Label Mix-up
Bryant Ranch Prepack has recalled Morphine Sulfate extended-release tablets due to a label mix-up where bottles may contain the wrong strength. Contact your pharmacy to verify your correct dose.
Product
Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., NJ; Relabeled by: Bryant Ranch Prepack, Inc, CA, NDC 63629-1089-01
Category
Drug
Distribution
1 state
CriticalFDA (Devices)·Z-1319-2022·2022-07-13
Palindrome HSI Chronic Catheter Recalled for Potential Hub Leaking
Covidien is recalling Palindrome HSI Chronic Catheters due to a potential leaking condition in the catheter hub that may cause unanticipated fluid return during dialysis. Approximately 13,526 units distributed worldwide are affected.
Product
Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1399-2022·2022-07-13
Giant Eagle Cupcakes Recalled Due to Salmonella Contamination Risk
Giant Eagle Cupcakes (GE Cupcake 6 Buckeye, 18Oz) recalled due to potential Salmonella contamination from Jiff Peanut Butter. 14 units distributed to Pennsylvania.
Product
GE 29765500000 Cupcake 6 Buckeye 18Oz
Category
Food
Distribution
1 state
CriticalFDA (Food)·F-1402-2022·2022-07-13
Prairie City Bakery Peanut Butter Chocolate Chip Cakes Recalled for Salmonella
Prairie City Bakery is recalling Peanut Butter Chocolate Chip Ooey Gooey Butter Cakes due to Salmonella contamination from recalled Jif peanut butter ingredient. Products were distributed to gas stations and convenience stores nationwide.
Product
Prairie City Bakery Peanut Butter Chocolate Chip Ooey Gooey Butter Cake 2oz. individual UPC: 7-9788436718-2; 10 individual units per display unit; 6 display units per wholesale case.
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1380-2022·2022-07-06
Wawa Apples & Peanut Butter Dippers Recalled for Possible Salmonella Contamination
Taylor Farms Florida is recalling Wawa Apples & Peanut Butter dipper snack cups due to possible Salmonella contamination in the JM Smucker's Jif peanut butter component. Approximately 7,942 units distributed to Wawa locations in Florida are affected.
Product
Wawa Apples & Peanut Butter dipper 4.9oz. snack plastic cups
Category
Food
Distribution
1 state
CriticalFDA (Drugs)·D-1160-2022·2022-07-06
Nasal Swab Remedy for Kids Recalled for Microbial Contamination
Allergy Bee Gone for Kids Nasal Swab Remedy is recalled due to FDA-confirmed microbial contamination including yeast, mold, and Bacillus cereus. Affected consumers should stop using the product.
Product
Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ (10 mL) tubes, UPC Code 860002022116
Category
Drug
Distribution
0 states
CriticalFDA (Food)·F-1339-2022·2022-06-29
Peanut Butter Fudge Recalled Due to Potential Salmonella Contamination
Calico Cottage Inc is recalling Peanuttiest Caramel Chocolate fudge nationwide because the peanut butter ingredient may be contaminated with Salmonella.
Product
1. PEANUTTIEST CARAMEL CHOCOLATE P-MADE(6SS)6LB NT WT - not consumer packaging, bulk carton
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1353-2022·2022-06-29
Giai Phat Fried Featherback Fish Ball Recalled for Undeclared Egg
Chaur Fong Inc. is recalling Giai Phat Fried Featherback Fish Ball (10 oz bags) because the product contains undeclared egg, a major allergen not disclosed on the label.
Product
Giai Phat Fried Featherback Fish Ball NET WT. 10 oz. (283g) Keep Product Refrigerated at 38F or Below/May Be Frozen Ingredients: Fish meat (may contain surimi (Japanese Threadfin Bream Fish, Sugar, Polyphosphate) Lady Fish and or Featherback Fish), Water, Tapioca Flour, Salt, M
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-1329-2022·2022-06-29
Albertsons Deli Snack Peanut Butter & Trail Mix Recalled for Salmonella Risk
Albertsons Companies is recalling Deli Snack Peanut Butter & Trail Mix products for potential Salmonella contamination. Affected products have sell-through dates on or before May 26, 2022.
Product
Deli Snack Peanut Butter & Trail Mix Combo. Product were available for purchase at the following banners: Albertsons, Carrs-Safeway, Eagle, Randalls, Safeway, Tom Thumb. Packaged in clear plastic square bottom and lid. Net wt. 9 oz.
Category
Food
Distribution
0 states
CriticalFDA (Food)·F-1354-2022·2022-06-29
Frozen Cuttle Fish Balls Recalled for Undeclared Egg Allergen
Giai Phat Cuttle Fish Balls (8 oz bags) are recalled due to undeclared egg. Approximately 335,401 bags were distributed in California, Illinois, and Idaho.
Product
Giai Phat Cuttle Fish Ball NET WT. 8 oz. (227g) Keep Frozen Open Package Before Thawing Item # 31108 Ingredients: Cuttle Fish, Surimi (Japanese Threadfin Bream Fish, Sugar, Polyphosphate), Water, Tapioca Flour, Salt, Monosodium Glutamate, Garlic Powder, White Pepper, Baking P
Category
Food
Distribution
3 states