The Recall Desk

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.

4326–4350 of 4878

  • SevereFDA (Drugs)·D-0238-2022·2021-11-24

    LOTRIMIN AF Powder Spray Recalled for Benzene Contamination Risk

    Bayer Healthcare is recalling LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray because it was manufactured at a facility where other lots were found contaminated with benzene. The recall affects multiple lot numbers distributed nationwide in the US, Puerto Rico, Canada, and Mexico.

    Product
    LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 pack, NDC 11523-0544-2, UPC 0 41100 58594 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, ,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0193-2022·2021-11-24

    HelloFresh Meal Kits Recalled for Salmonella-Contaminated Onions

    HelloFresh is recalling meal kits containing onions from ProSource that are associated with a Salmonella Oranienburg outbreak. The affected product code is 1-2-3-5-9-11-15-17-19-25 from production week starting August 4, 2021.

    Product
    HelloFresh Meal Kit Product Code 1-2-3-5-9-11-15-17-19-25 from Production Week 32 (production week start date: 8/4/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0171-2022·2021-11-24

    Whole White Onions Recalled for Potential Salmonella Contamination

    Keeler Family Farms is recalling whole white onions imported from Chihuahua, Mexico due to potential contamination with Salmonella Oranienburg. The affected onions were shipped between July 1 and August 25, 2021.

    Product
    Whole raw onions - WHITE - imported from Chihuahua, Mexico and shipped from July 1, 2021 through August 25, 2021. Products are packaged in 25 lb. and 50 lb. mesh bags. One pallet contains 42 bags. Store in cool dry place off the ground. Labeling will state product of Mexico on bi
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0253-2022·2021-11-24

    Tinactin Tolnaftate Powder Spray Recalled Due to Benzene Contamination

    Bayer Healthcare Pharmaceuticals is recalling Tinactin (Tolnaftate 1%) Powder Spray because some cans contain benzene contamination. Consumers should stop using affected lots and consult a healthcare provider.

    Product
    Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0232-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device Catheter Lumen Detachment Recall

    Arrow International is recalling Arrow-Trerotola Percutaneous Thrombolytic Device catheters because the inner lumen can detach from the device basket, causing embolization requiring additional intervention and delaying dialysis therapy. Approximately 1,245 units are affected worldwide.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-veno
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0188-2022·2021-11-24

    Fisherman's Wharf Cooked Shrimp Recalled for Listeria Risk

    Fisherman's Wharf Shrimp 16/20 Cooked Shrimp 16oz packages are being recalled due to potential contamination with Listeria monocytogenes. The affected products were distributed domestically with specific serial numbers and best-by dates in early April 2023.

    Product
    Fisherman's Wharf, Shrimp 16 /20 Cooked Shrimp 16oz 7306067
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0199-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella Contamination

    EveryPlate meal kits with product codes 83, 84, 86, 89, 92, 94, and 97 from production week July 14, 2021, are recalled due to onions contaminated with Salmonella Oranienburg. The affected onions were purchased from ProSource.

    Product
    EveryPlate Meal Kit Product Codes 83-84-86-89-92-94-97 from Production Week 29 (production week start date: 07/14/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0205-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella Contamination

    HelloFresh is recalling specific EveryPlate meal kits containing onions from ProSource that are associated with a Salmonella Oranienburg outbreak. Affected product codes from production week 08/25/2021 are being recalled nationwide.

    Product
    EveryPlate Meal Kit Product Codes 87-88-89-90-91-94-101 from Production Week 35 (production week start date: 08/25/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0225-2022·2021-11-24

    Scrip Creme ultrasound lotion recalled for bacterial contamination

    Scrip Creme All Purpose Lotion is being recalled due to bacterial contamination in this ultrasound coupling lotion. The product—1001 gallons in lots distributed between August 2018 and August 2021—was distributed nationwide.

    Product
    Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0201-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella Contamination

    HELLOFRESH US is recalling specific EveryPlate meal kits containing onions from ProSource linked to a Salmonella Oranienburg outbreak. The affected products were produced in week 31, 2021.

    Product
    EveryPlate Meal Kit Product Codes 82-83-84-90-91-92-94-96-97-100 from Production Week 31 (production week start date: 07/28/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0246-2022·2021-11-24

    Lotrimin AF Deodorant Powder Spray Recalled for Benzene Contamination

    Bayer Healthcare is recalling Lotrimin AF Deodorant Powder Spray (Miconazole nitrate 2%) nationwide due to the presence of benzene contamination. The recall affects approximately 2.8 million cans distributed across the US, Puerto Rico, Canada, and Mexico.

    Product
    LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0173-2022·2021-11-24

    Red Onions Recalled for Potential Salmonella Contamination

    Sysco Merchandising and Supply is recalling 2,902 cases of red onions packed in 5-pound bags due to potential Salmonella contamination. The onions were distributed to multiple states.

    Product
    Red onions packed in 5 pound bag
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-0208-2022·2021-11-24

    Marketside Garden Salad recalled due to Listeria contamination

    Dole Fresh Vegetables Inc is recalling Marketside Classic Salad (Garden Salad) because samples tested positive for Listeria monocytogenes. The product was distributed to multiple states.

    Product
    Marketside Classic Salad; Garden Salad; iceberg lettuce, shredded carrots, red cabbage; Net Wt. 24 oz. (1 lb. 8 oz.) 680 g UPC: 6-81131-32895-1 Distributed by Walmart, Bentonville, AR
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0203-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella-Contaminated Onions

    HELLOFRESH US is recalling specific EveryPlate meal kit product codes from production week 08/11/2021 nationwide due to onions contaminated with Salmonella Oranienburg purchased from ProSource.

    Product
    EveryPlate Meal Kit Product Codes 80-82-84-85-88-90-92-99 from Production Week 33 (production week start date: 08/11/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0204-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella Contamination Risk

    EveryPlate meal kits with specific product codes from production week 34 (starting 08/18/2021) are being recalled nationwide because onion ingredients from ProSource are associated with a Salmonella Oranienburg outbreak.

    Product
    EveryPlate Meal Kit Product Codes 82-84-85-87-88-90-92-97-98 from Production Week 34 (production week start date: 08/18/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0233-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device inner lumen detachment and embolization risk

    Arrow-Trerotola PTD catheters are being recalled because the inner lumen can detach from the device basket, causing embolization that requires additional intervention. 1,167 units are affected.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0190-2022·2021-11-24

    HelloFresh Meal Kits Recalled for Salmonella Contamination

    HelloFresh is recalling certain meal kits containing onions from ProSource that are associated with a Salmonella Oranienburg outbreak. The affected kits have Product Codes 2-5-8-9-16-19-21-22-23-24-25 from Production Week 29 (starting July 14, 2021) and were distributed nationwide.

    Product
    HelloFresh Meal Kit Product Code 2-5-8-9-16-19-21-22-23-24-25 from Production Week 29 (production week start date: 07/14/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0200-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella Contamination

    HelloFresh US is recalling specific EveryPlate meal kits containing onions contaminated with Salmonella Oranienburg. The affected products are from production week starting July 21, 2021, with product codes 84, 88, 89, 90, 91, 92, 94, 98, 99, and 100.

    Product
    EveryPlate Meal Kit Product Codes 84-88-89-90-91-92-94-98-99-100 from Production Week 30 (production week start date: 07/21/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0206-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella-Contaminated Onions

    EveryPlate meal kits distributed nationwide are being recalled because they contain onions purchased from ProSource that are associated with a Salmonella Oranienburg outbreak.

    Product
    EveryPlate Meal Kit Product Codes 82-83-89-93-94-96-98 from Production Week 36 (production week start date: 09/01/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereCPSC·22021·2021-11-18

    Goodman evaporator coil drain pans recalled for fire hazard

    Goodman Manufacturing is recalling evaporator coil drain pans used in residential gas furnaces because the plastic drain pan can overheat, melt, and deform, posing a fire hazard. The company has received 23 reports of fire incidents involving the drain pans, resulting in significant fire and smoke damage to residences.

    Product
    Evaporator coil drain pans installed with residential condensing gas furnaces in an up-flow configuration
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0209-2022·2021-11-17

    TRI-MIX Papaverine/Phentolamine/PGE-1 Injectable Recalled for Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 40 injectable vials due to lack of assurance of sterility. The recalled product was distributed across the United States including Washington, D.C. and Puerto Rico.

    Product
    TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0205-2022·2021-11-17

    Tri-Mix Papaverine Injectable Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 30/Phentolamine 1/PGE-1 2.5 injectable due to lack of assurance of sterility. The recall affects 30 vials distributed across the United States.

    Product
    TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 2.5 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0178-2022·2021-11-17

    Testosterone Cypionate and Anastrozole Injectable Recall Due to Sterility Assurance Lack

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling testosterone cypionate 200mg/anastrozole 1mg/ml injectable vials distributed across the United States, Puerto Rico, and Washington, D.C. due to lack of assurance of sterility.

    Product
    TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0152-2022·2021-11-17

    Talon Compounding Pharmacy Injectable Recalled for Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a testosterone cypionate injectable combination product due to lack of assurance of sterility. The product was distributed in the United States.

    Product
    TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.75MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0176-2022·2021-11-17

    Testosterone Cypionate/Anastrozole Injectable Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling testosterone cypionate 200 mg/anastrozole 1.75 mg/mL injectable due to lack of assurance of sterility. The affected lot was distributed across the United States including Washington, D.C. and Puerto Rico.

    Product
    TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1.75MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states