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.

3751–3775 of 4878

SevereCPSC·22108·2022-03-24
EGL and ACE Youth ATVs Recalled for Safety Standard Violations
EGL Motor is recalling about 500 EGL and ACE-branded youth ATVs (models MADIX 110 and B125) sold nationwide from May to September 2020 due to violations of federal ATV safety standards. The vehicles exceed speed limits for their age group, have defective brakes, and handlebars that pose laceration hazards in crashes.
Product
EGL and ACE-branded Youth All-Terrain Vehicles (ATVs)
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0725-2022·2022-03-23
Avaphinal Maximum Male Enhancement Pills Recalled for Undeclared Drug
Walmart is recalling Avaphinal Maximum Male Enhancement Sexual Pills (2000 MG, 10-capsule cartons, Lot DK1027) distributed nationwide because they contain undeclared sildenafil, making them an unapproved drug.
Product
Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0661-2022·2022-03-23
Trimix Injectable Vials Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling Trimix (Alprostadil/Papaverine/Phentolamine) injectable vials distributed in North Carolina due to lack of assurance of sterility.
Product
Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-0864-2022·2022-03-23
Albanese Dark Chocolate Espresso Beans recalled due to undeclared peanut allergen
Albanese Confectionery is recalling specific lots of its Dark Chocolate Espresso Bean tubs due to undeclared peanut allergen. Consumers with peanut allergies who purchased this product should not consume it.
Product
Albanese Dark Chocolate Espresso Bean packaged into 9oz plastic tubs 12 tubs per case
Category
Food
Distribution
1 state
SevereFDA (Drugs)·D-0659-2022·2022-03-23
Hydromorphone HCl Infusion Recall Due to Sterility Assurance
Family Pharmacy of Statesville is recalling one lot of Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags due to lack of assurance of sterility.
Product
Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0666-2022·2022-03-23
Methylcobalamin Injectable Recalled Due to Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling Methylcobalamin 1 mg/mL Injectable in 1 mL syringes (Lot #07282020@3) distributed in North Carolina because the manufacturer cannot assure the product meets sterility standards.
Product
Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0656-2022·2022-03-23
Hydromorphone HCl Infusion Bags Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling Hydromorphone HCl 2 mg/mL Infusion 250 mL bags (2 units) distributed in North Carolina due to lack of assurance of sterility.
Product
Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0657-2022·2022-03-23
Hydromorphone HCl 1 mg/mL 250 mL Bags Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling four bags of Hydromorphone HCl 1 mg/mL (250 mL each) distributed in North Carolina due to lack of assurance of sterility. The affected lots have beyond-use dates of October 25–30, 2020.
Product
Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-0866-2022·2022-03-23
Frozen Breakfast Tarts Recalled for Undeclared Almonds
Gourmet Kitchen, Inc. is recalling 59 boxes of 14" Raw Buttermilk Breakfast Tart with Fresh Blueberries & Granola because they contain undeclared almonds, a tree nut allergen.
Product
14" Raw Buttermilk Breakfast Tart with Fresh Blueberries & Granola P2006 (9 Frozen Pancakes). Barcode:0106915030162006992202425990
Category
Food
Distribution
12 states
SevereFDA (Drugs)·D-0662-2022·2022-03-23
Vancomycin Ophthalmic Solution Recalled Due to Sterility Concerns
Family Pharmacy of Statesville is recalling Vancomycin 14 mg/mL Fortified Ophthalmic Solution due to lack of assurance of sterility. The affected lot was distributed in North Carolina.
Product
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-0863-2022·2022-03-23
Multiple ice cream brands recalled for Listeria monocytogenes contamination
Ice cream products manufactured by Royal Ice Cream Company in Manchester, CT are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed across multiple states under various retail and food service brand names.
Product
All Ice Cream and Ice Cream products within expiry; manufactured by Royal Ice Cream Company; manufactured in Manchester, CT; all effected products will have the manufacturing plant number "CT121" or "CT #121"; RETAIL BRANDS EFFECTED: Batch brand pints, all flavors; Royal Ice Crea
Category
Food
Distribution
21 states
SevereFDA (Drugs)·D-0664-2022·2022-03-23
Ketamine 50 mg Infusion Solution Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling three bags of Ketamine 50 mg Infusion Solution because the manufacturer cannot assure sterility of the product.
Product
Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-0719-2022·2022-03-23
Unauthorized COVID-19 Diagnostic Test Kits Imported Without FDA Approval
SD Biosensor's STANDARD Q COVID-19 Ag Home Test kits were illegally imported without FDA approval, clearance, or authorization. Approximately 400,000 units were distributed nationwide.
Product
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0862-2022·2022-03-23
Helmi Honey VIP Recalled for Undisclosed Drug Ingredient
Helmi Honey VIP is being recalled nationwide due to the presence of an undisclosed drug ingredient. Consumers should stop using the product and return it.
Product
Helmi Honey VIP packaged in a gold paper box with black writing, 12 sachets per box UPC 3553314122014
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0663-2022·2022-03-23
Morphine Sulfate Infusion Recall Due to Sterility Assurance Failure
Family Pharmacy of Statesville is recalling Morphine Sulfate 6 mg/mL infusions in 250 mL bags due to lack of assurance of sterility. The affected product was distributed in North Carolina.
Product
Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0667-2022·2022-03-23
Fentanyl Infusion Solution Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling one lot of Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags because the manufacturer cannot assure the product's sterility.
Product
Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-0861-2022·2022-03-23
Jaguar Power Honey Recalled Nationwide for Hidden Drug Ingredient
Jaguar Power Honey packaged in gold boxes is being recalled nationwide because it contains a hidden drug ingredient not listed on the label. Consumers should not consume this product.
Product
Jaguar Power Honey packaged in a gold paper box with black writing, 12 sachets per box UPC 3553314142227
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-0865-2022·2022-03-23
Frozen Breakfast Tarts Recalled Due to Undeclared Almonds
Gourmet Kitchen, Inc. is recalling 43 boxes of Raw Buttermilk Breakfast Tarts due to undeclared almonds. Consumers allergic to almonds should not consume this product.
Product
14" Raw Buttermilk Breakfast Tart with Cranberries, Apples & Granola P2004 (9 Frozen Pancakes). Barcode: 0106915030162004992201921137
Category
Food
Distribution
12 states
SevereFDA (Drugs)·D-0658-2022·2022-03-23
Hydromorphone HCl 5 mg/mL Infusion Recall Due to Sterility Assurance
Family Pharmacy of Statesville is recalling Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags because the manufacturer cannot assure the product meets sterility requirements.
Product
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0655-2022·2022-03-23
B. Braun 0.9% Sodium Chloride Injection bags recalled for leaking
B. Braun Medical, Inc. is recalling 33,742 bags of 0.9% Sodium Chloride Injection USP due to leaking that compromises sterility assurance. The intravenous medication was distributed nationwide.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0665-2022·2022-03-23
Lorazepam 1 mg/mL Infusion Solution Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling Lorazepam 1 mg/mL Infusion Solution in 250 mL bags because the manufacturer cannot assure sterility of the product.
Product
Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereCPSC·22734·2022-03-17
ToolGuards Portable Water Immersion Heaters Recalled for Shock and Fire Hazards
FXswede AB is recalling about 5,000 ToolGuards Portable Water Immersion Heaters sold on Amazon.com because the units can overheat, melt, or catch fire, creating electrocution and fire hazards. The firm has received 19 reports of overheating or fires and 2 reports of consumer shock.
Product
ToolGuards Portable Water Immersion Heaters
Category
Consumer Product
Distribution
Distributed nationwide
SevereFDA (Food)·F-0948-2022·2022-03-16
Abbott infant formula recalled due to bacterial contamination
Abbott Laboratories is recalling EleCare and Similac EleCare infant formula due to consumer complaints of Cronobacter sakazakii and Salmonella Newport infections in infants, and Cronobacter contamination in the manufacturing facility.
Product
Abbott EleCare, EleCare LCP Hypoallergenic, Similac EleCare 400g. can. 6 cans per case. Item numbers: 5351034 5351066 5351039 5351077 Retail UPCs: 17703186031461 9340104000706 17501033957748 070074119281
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-0919-2022·2022-03-16
Abbott Similac Human Milk Fortifier Recalled Due to Pathogen Risk
Abbott Similac Human Milk Fortifier pouches are recalled due to potential Cronobacter sakazakii and Salmonella Newport contamination. The recall affects infants who may have received contaminated product.
Product
Abbott Similac Human Milk Fortifier 0.9g Pouch / Sachet, 50 Pouch / Sachet per retail unit. 3 retail units per case Item numbers: 54598 5459813 5459814 5459820 5459886 6771009 Retail UPCs: 70074545998 070074545998 055325545996 070074109404 070074103297 07007467
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-0952-2022·2022-03-16
Abbott EleCare Jr Amino Acid Powder Recalled for Pathogenic Bacteria
Abbott EleCare Jr Amino Acid-Based Nutrition Powder (banana) is recalled due to consumer complaints of Cronobacter sakazakii or Salmonella Newport in infants, with pathogen evidence in the manufacturing facility.
Product
Abbott EleCare Jr Amino Acid-Based Nutrition Powder Banana 14.1oz. can. 6 cans per case. Item numbers: 66275 Retail UPCs: 070074662763
Category
Food
Distribution
Distributed nationwide