Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

6151–6175 of 29110

SevereFDA (Food)·F-1618-2022·2022-09-07
Plant Protein Drink Recalled Nationwide for Cronobacter and Botulism Contamination Risk
Lyons Magnus recalls its pirq Plant Protein Super Foods drink nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should discard or return the product.
Product
pirq Plant Protein Super Foods, Decadent Chocolate Drink, Almonds, Curcumin, Maca. 11 FL OZ (325ML). UPC 8 57690-00806 5. Packaged in the following configurations: 1. 12 count case UPC 857690008164. 2. 4 count wrap UPC 857690008317. Chill it, Shake it. Do not
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1600-2022·2022-09-07
Abbott Glucerna Rich Chocolate Shake recalled nationwide for pathogenic bacteria
Lyons Magnus is recalling Glucerna original Rich Chocolate Shake nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The recall affects approximately 53.8 million units distributed across the U.S.
Product
Glucerna original Rich Chocolate Shake, 8 FL OZ (237 mL). Delicious Snack or Small Meal Replacement. UPC 0 70074-68565 6. Sold in 24 count case, UPC Case 0070074685649. Shake Well. Serve cold. Refrigerate after opening. Manufactured for: Abbott Nutrition, Abbott Labora
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1612-2022·2022-09-07
Lyons Ready Care Thickened Dairy Drink Recalled for Bacterial Contamination
Lyons Magnus is recalling Lyons Ready Care Thickened Dairy Drink nationwide due to findings and potential for Cronobacter sakazakii and Clostridium botulinum contamination.
Product
Lyons Ready Care Thickened Dairy Drink. Moderately Thick Honey Consistency. Pasteurized - Grade A Made with 2% Milk Fat Milk, Vitamins A & D Packaged in the following sized Tetra Pak containers: 1. 8 FL OZ (237 mL) UPC 0 45796-10044 2. Item 10044. 24 count case UPC 1004
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1633-2022·2022-09-07
Sysco Imperial Med Plus Nutritional Drink Recalled for Bacterial Contamination
Sysco Imperial Med Plus NSA 1.7 Vanilla Nutritional Drink has been recalled nationwide due to findings and potential contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume the product.
Product
Sysco Imperial Med Plus NSA 1.7 Vanilla Nutritional Drink. High Calorie, High Protein. Mildly Thick Nectar Consistency. 32 FL OZ (1 QT) 946mL UPC 7 34730-31074 9. Reorder # 0794018. 12 count case UPC 10734730310746. Refrigerate prior to serving. Shake well. Refr
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1674-2022·2022-09-07
Oatly Oat Drink Chocolate Recalled Due to Pathogen Contamination Risk
Lyons Magnus is recalling Oatly Oat Drink Chocolate nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume the affected product.
Product
The Original Oatly! Oat Drink Chocolate 11 fl oz (330ml). UPC 1 90646-63015 7. 18 count case UPC 20190646630151. Distributed by Oatly Inc., 220 E 42ndSt., Ste. 409A, New York, NY 10017.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1631-2022·2022-09-07
Sysco Imperial Dairy Drink Recalled for Cronobacter and Botulism
Lyons Magnus recalled Sysco Imperial Thickened Dairy Drink nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination. The FDA Class I recall affects over 53 million units distributed in 8 oz and 32 oz containers.
Product
Sysco Imperial Thickened Dairy Drink. Moderately Thick Honey Consistency. Pasteurized - Made with Grade A 2% Fat Milk, Vitamins A & D. Packaged in the following sized Tetra Pak containers: 1. 8 FL OZ (237 mL) UPC 0 74865-94550 9. Reorder # 0429357. 24 count case UPC
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1632-2022·2022-09-07
Sysco Imperial Med Plus Vanilla Nutritional Drink Recalled for Bacterial Contamination
Lyons Magnus recalls Sysco Imperial Med Plus Vanilla Nutritional Drink nationwide for Cronobacter sakazakii and Clostridium botulinum contamination. The recall affects 53,818,025 units.
Product
Sysco Imperial Med Plus 2.0 Vanilla Nutritional Drink. High Calorie, High Protein. Mildly Thick Nectar Consistency. 32 FL OZ (1 QT) 946mL UPC 0 74865-92730 7. Reorder # 0108910. 12 count case UPC 10074865927304. Refrigerate prior to serving. Shake well. Refrigerat
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1640-2022·2022-09-07
Stumptown Cold Brew Coffee Recalled for Potential Bacterial Contamination
Stumptown Cold Brew Coffee with Oat Milk Original is being recalled due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected products were distributed nationwide.
Product
Stumptown Cold Brew Coffee with Oat Milk Original. Plant Based. Low Sugar. Made with Oatly! 11 Fl Oz. 325 ML. UPC 8 55186-00687 8. Sold in 12-count case UPC 108551860006875. Manufactured for Stumptown Coffee Roasters, 100 SE Salmon St. Portland, OR 97214
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1602-2022·2022-09-07
Glucerna original Vanilla Shake recalled for bacterial contamination
Lyons Magnus is recalling Glucerna original Vanilla Shake due to findings of Cronobacter sakazakii and potential Clostridium botulinum. Over 53 million units were distributed nationwide.
Product
Glucerna original Homemade Vanilla Shake, 8 FL OZ (237 mL). Delicious Snack or Small Meal Replacement. UPC 0 70074-68563 2. Sold in 24 count case, Case UPC 0070074685625. Shake Well. Serve cold. Refrigerate after opening. Manufactured for: Abbott Nutrition, Abbott Labor
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1653-2022·2022-09-07
Uproot Peamilk Chocolate Recalled for Cronobacter and Botulism Risk
Lyons Magnus is recalling Uproot Peamilk Chocolate nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The recall affects 53,818,025 units.
Product
Uproot Peamilk Chocolate 8 fl oz. (240mL) UPC 8 60002-91544 9. Serve chilled, refrigerate after opening and use within 7 days. Manufactured for Uproot, Inc., New York, NY 10005. Sold in 18-count case UPC 10860002915446. .
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1642-2022·2022-09-07
Stumptown Cold Brew Coffee with Oat Milk Recalled for Bacterial Contamination Risk
Lyons Magnus is recalling Stumptown Cold Brew Coffee with Oat Milk nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume the affected product.
Product
Stumptown Cold Brew Coffee with Oat Milk Horchata. Plant Based. Made with Oatly! 11 Fl Oz. 325 ML. UPC 8 55186-00689 2. Sold in 12-count case UPC 108551860006892. Manufactured for Stumptown Coffee Roasters, 100 SE Salmon St. Portland, OR 97214
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1629-2022·2022-09-07
MRE Vanilla Protein Shake Recalled for Potential Bacterial Contamination
Lyons Magnus is recalling MRE Vanilla Protein Shake nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum bacteria.
Product
MRE Vanilla Protein Shake. Whole Food Protein High protein shake. 11 FL OZ (325mL) Tetra Pak. UPC 8 10044-57390 9. 4-count case UPC 810044573954. Refrigerate after Opening. Distributed by: Redcon1, LLC, 701 Park of Commerce Blvd, Boca Raton, FL 33487
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1656-2022·2022-09-07
Organic Valley Organic Whole Milk recalled for potential Cronobacter and botulinum contamination
Lyons Magnus is recalling approximately 53.8 million units of Organic Valley Organic Whole Milk nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum.
Product
Organic Valley Organic Whole Milk. 8 fl oz UPC 0 93966-00818 0. 12 Count Case UPC 00093966008531.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1655-2022·2022-09-07
Organic Valley 1% lowfat milk recalled nationwide for pathogenic contamination
Lyons Magnus is recalling Organic Valley 1% lowfat milk nationwide due to Cronobacter sakazakii and Clostridium botulinum contamination. Consumers should not consume the affected product.
Product
Organic Valley Organic 1% Milkfat Lowfat Milk. 8 fl oz UPC 0 93966-00837 1. 12 Count wrap UPC 00093966008524. Chill and Shake before serving. Refrigerate after opening. Distributed by CROPP Cooperative La Farge, WI 54639.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1625-2022·2022-09-07
Premier Protein Cafe Latte Shakes Recalled for Pathogenic Bacteria
Premier Nutrition is recalling Premier Protein Cafe Latte shakes distributed nationwide due to contamination findings with Cronobacter sakazakii and Clostridium botulinum bacteria. Over 53 million units are affected.
Product
Premier Protein Cafe Latte High protein shake. 11 FL OZ (325mL). Packaged in the following configurations: 1. Carton UPC 6 43843-71668 6 packed in 4 count wrap UPC 643843716679. 2. Carton UPC 6 43843-71665 5 packed in 18 count case UPC 643843718567. Shake Well
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1670-2022·2022-09-07
Kate Farms Nutritional Formula Recalled for Cronobacter and Botulism Risk
Kate Farms Standard 1.4 Cal/mL nutrition formula in 325 mL bottles is recalled nationwide due to potential Cronobacter sakazakii and Clostridium botulinum. Affected lot code 8031 has best-by date November 4, 2022.
Product
kate farms Standard 1.4 Cal/mL, Plain, Sole-Source Nutrition Formula. 325 mL (11 fl oz) UPC 8 11112-03001 0. 12 count case UPC 00811112030027. Shake Well. A ready-to-use oral and tube feeding formula. Made for Kate Farms, Inc., 101 Innovation Place, Santa Barbara, CA 9370
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1607-2022·2022-09-07
Cold Coffee Recalled Nationwide for Bacterial Contamination Risk
Intelligentsia Cold Coffee in 10.9 oz containers is recalled nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination. Consumers should not consume the product.
Product
Intelligentsia, Cold Coffee. Net 10.9 fl oz (325 mL) Tetra Pak container UPC 8 00222-00096 9. Shake Best enjoyed cold. Refrigerate after opening. Produced for: Intelligentsia Coffee, Inc., Aloha, Chicago, IL 60612.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1663-2022·2022-09-07
Abbott PediaSure Harvest 1.0 Cal tube-feeding formula recalled nationwide
Abbott PediaSure Harvest 1.0 Cal tube-feeding formula is recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Approximately 53,818,025 units with specific lot codes spanning September 2022 through April 2023 are affected.
Product
Abbott PediaSure Harvest 1.0 Cal, For Tube Feeding. Complete nutrition blend. 8 fl oz (237mL). UPC 0 70074-67963 1. 24 count case UPC 00070074679624. Shake very well. Store unopened at room temperature. Once opened, reclose, refrigerate, and use within 24 hours. Manufact
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1626-2022·2022-09-07
Protein Shake Recalled Nationwide for Potential Bacterial Contamination
Lyons Magnus is recalling MRE Cookies & Cream Protein Shake nationwide due to potential findings of Cronobacter sakazakii and Clostridium botulinum. The FDA has classified this as a Class I recall.
Product
MRE Cookies & Cream Protein Shake. Whole Food Protein High protein shake. 11 FL OZ (325mL) Tetra Pak. UPC 8 10044-57389 3. 4-count case UPC 810044573961. Refrigerate after Opening. Distributed by: Redcon1, LLC, 701 Park of Commerce Blvd, Boca Raton, FL 33487
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1662-2022·2022-09-07
Optimum Nutrition whey protein recalled for potential botulinum and Cronobacter contamination
Optimum Nutrition Gold Standard 100% Whey Chocolate is recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Over 53 million units affected.
Product
Optimum Nutrition Gold Standard 100% Whey Chocolate 11 fl oz (325mL). UPC 7 48927-06409 4. Shake well. Best when served chilled. Manufactured for Optimum Nutrition, Inc., 3500 Lacey Road, Suite 1200, Downers Grove, IL 60515
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1623-2022·2022-09-07
Premier Protein Shakes Recalled for Potential Bacterial Contamination
Lyons Magnus is recalling Premier Protein Chocolate High Protein Shakes nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination. Consumers should not consume affected products and should return them.
Product
Premier Protein Chocolate High protein shake. 11 FL OZ (325mL). Packaged in the following configurations: 1. Carton UPC 6 43843-71447 7 packed in 12 count case UPC 643843714200. 2. Carton UPC 6 43843-71534 4 packed in 18 count case UPC 643843718581. Shake W
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1643-2022·2022-09-07
Stumptown Cold Brew Coffee Recalled Nationwide for Bacterial Contamination
Lyons Magnus Inc. is recalling Stumptown Cold Brew Coffee with Cream & Sugar nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum bacteria.
Product
Stumptown Cold Brew Coffee with Cream & Sugar Chocolate. 11 Fl Oz. 325 ML. UPC 8 55186-00686 1. Sold in 12-count case UPC 108551860006861. Manufactured for Stumptown Coffee Roasters, 100 SE Salmon St. Portland, OR 97214
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1604-2022·2022-09-07
Aloha Organic Protein Drink recalled for Cronobacter and botulism contamination
Lyons Magnus recalls Aloha Organic Protein Drink nationwide due to Cronobacter sakazakii and Clostridium botulinum contamination. The FDA Class I recall affects 53,818,025 units.
Product
Aloha Organic Protein Drink, Coconut Plant-based protein. Net 11 FL OZ (330 mL) Tetra Pak container UPC 8 42096-11237 9. Sold in 4 count package wrap with UPC 842096122378. Shake Well. Best Chilled. Manufactured for: Aloha, Littleton, CO 80127
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1628-2022·2022-09-07
MRE Salted Caramel Protein Shake Recalled for Cronobacter and Botulinum Risk
Lyons Magnus recalls MRE Salted Caramel Protein Shake nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination. Consumers should not consume affected products.
Product
MRE Salted Caramel Protein Shake. Whole Food Protein High protein shake. 11 FL OZ (325mL) Tetra Pak. UPC 8 10044-57392 3. 4-count case UPC 810044573930. Refrigerate after Opening. Distributed by: Redcon1, LLC, 701 Park of Commerce Blvd, Boca Raton, FL 33487
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1521-2022·2022-09-07
NIM EMG Endotracheal Tubes recalled for risk of airway obstruction
Medtronic Xomed is recalling NIM EMG Endotracheal Tubes due to reports of airway obstruction during use. The recall affects 23,820 units distributed worldwide.
Product
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
Category
Medical Device
Distribution
Distributed nationwide