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.

7626–7650 of 29121

  • SevereFDA (Food)·F-0094-2022·2021-11-10

    Chicken Flavor Food Additive Recalled for Salmonella Contamination

    Givaudan Flavours Corp is recalling a natural chicken rotisserie flavor product due to positive Salmonella detection. The affected batch was distributed to a single account in Indiana.

    Product
    AY-259-396-6 Nat Chicken (rotisserie) Flavor WONF 18.144kg packages packaged in brown square boxes with blue plastic interior
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0089-2022·2021-11-10

    Irbesartan and Hydrochlorothiazide Tablets Recalled for Impurity Contamination

    Lupin Pharmaceuticals is recalling Irbesartan and Hydrochlorothiazide Tablets 150/12.5 mg due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient, which resulted from CGMP deviations.

    Product
    Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0112-2022·2021-11-10

    Raw Yellow Onions from Mexico Recalled for Salmonella Oranienburg

    ProSource Produce LLC is recalling whole raw yellow onions imported from Chihuahua, Mexico, due to potential contamination with Salmonella Oranienburg. The affected onions were distributed across multiple U.S. states and Canadian provinces under various brand names.

    Product
    Whole raw YELLOW onions are imported from Chihuahua of MEXICO. Products are packaged in 50 lb., 25 lb., 10 lb., 5 lb., 3 lb., and 2 lb. mesh sacks and in 50 lb., 40 lb., 25 lb., 10 lb., and 5 lb. cartons. Products are distributed and/or sold under the brands Big Bull, Mark
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0111-2022·2021-11-10

    Raw Red Onions Recalled Due to Salmonella Oranienburg Risk

    ProSource Produce LLC has recalled whole raw red onions imported from Chihuahua, Mexico, due to potential Salmonella Oranienburg contamination. The affected product was distributed across multiple U.S. states and Canadian provinces.

    Product
    Whole raw RED onions are imported from Chihuahua of MEXICO. Products are packaged in 50 lb., 25 lb., 10 lb., 5 lb., 3 lb., and 2 lb. mesh sacks and in 50 lb., 40 lb., 25 lb., 10 lb., and 5 lb. cartons. Products are distributed and/or sold under the brands Big Bull, Markon
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Devices)·Z-0194-2022·2021-11-10

    IPL Coupling Gel and EcoGel 200 Recalled for Bacterial Contamination

    Lumenis, Inc. is recalling IPL Coupling Gel and EcoGel 200 due to potential bacterial contamination. Approximately 11,064 units were distributed worldwide.

    Product
    IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0113-2022·2021-11-10

    ProSource Produce white onions recall for Salmonella contamination

    ProSource Produce LLC is recalling whole raw white onions imported from Mexico due to potential Salmonella Oranienburg contamination. The onions were distributed across 33 U.S. states and Canada.

    Product
    Whole raw WHITE onions are imported from Chihuahua of MEXICO. Products are packaged in 50 lb., 25 lb., 10 lb., 5 lb., 3 lb., and 2 lb. mesh sacks and in 50 lb., 40 lb., 25 lb., 10 lb., and 5 lb. cartons. Products are distributed and/or sold under the brands Big Bull, Marko
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Drugs)·D-0092-2022·2021-11-10

    Methocarbamol Tablets Mislabeled with Incorrect Strength

    Bryant Ranch Prepack is recalling Methocarbamol 500mg tablets nationwide because the bottles are mislabeled—they actually contain 750mg tablets. The affected lot was distributed in 30-, 60-, and 90-count bottles.

    Product
    Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0087-2022·2021-11-10

    Irbesartan Tablets Recalled for Impurity in Active Ingredient

    Lupin Pharmaceuticals is recalling Irbesartan tablets due to the detection of N-nitrosoirbesartan impurity in the active pharmaceutical ingredient. The recall affects 30-count and 90-count bottles distributed nationwide.

    Product
    IRBESARTAN — IRBESARTAN (IRBESARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V872000·2021-11-10

    Maserati Vehicles Recall: Fuel Line Sensor Housing May Crack and Leak

    Maserati is recalling certain 2021-2022 model-year vehicles due to a defective fuel line sensor housing that may crack and leak fuel. The leak can cause engine stall or fire, increasing crash risk.

    Product
    MASERATI — MASERATI GHIBLI, QUATTROPORTE, LEVANTE, MC20
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V873000·2021-11-10

    Jeep Wagoneer and Grand Cherokee Airbag Control Software Defect

    The Occupant Restraint Controller software in certain 2021-2022 Jeep models may be faulty, allowing airbags to disable without warning. This increases crash injury risk.

    Product
    JEEP — JEEP GRAND CHEROKEE, GRAND WAGONEER, WAGONEER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·043-2021·2021-11-10

    Innovative Solutions Recalls Chicken Patties Due to Possible Bone Contamination

    Innovative Solutions, Inc. is recalling raw chicken patty products that may contain pieces of bone. No illnesses have been reported.

    Product
    Innovative Solutions, Inc — Innovative Solutions, Inc. Recalls Chicken Patty Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0093-2022·2021-11-10

    Cubicin daptomycin injection recalled for glass particle contamination

    Merck Sharp & Dohme Corp. is recalling Cubicin (daptomycin for injection) 500 mg vials due to the presence of glass particles. The recall affects a single lot distributed nationwide.

    Product
    Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V864000·2021-11-05

    Steering shaft defect in 2021-2022 Western Star 49X commercial trucks

    2021-2022 Western Star 49X trucks may have improperly installed steering shafts that can separate, causing loss of steering control. Daimler will inspect and repair affected vehicles free of charge.

    Product
    WESTERN STAR — WESTERN STAR 49X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V861000·2021-11-05

    Isuzu and Chevrolet Trucks Recalled for Steering Knuckle Bolt Issue

    Isuzu is recalling 2018-2021 FTR and Chevrolet 6500XD trucks because a steering bolt may loosen, causing difficulty steering and increased crash risk.

    Product
    ISUZU — ISUZU, CHEVROLET FTR, 6500XD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V858000·2021-11-04

    Volvo Recalls 2021 VNL Trucks Due to Power Steering Pump Defect

    Volvo Trucks North America is recalling 2021 VNL vehicles because a machining defect in the power steering pump may cause a loss of steering assist, increasing crash risk.

    Product
    VOLVO — VOLVO VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0047-2022·2021-11-03

    TEST CYP/PROP Compounded Injection Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling TEST CYP/PROP 160/40MG/ML MDV in ethyl oleate due to FDA inspection findings that raised concerns about sterility assurance. Approximately 494 patients in multiple states received affected prescriptions.

    Product
    TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0039-2022·2021-11-03

    Hydroxyprogesterone Caproate Injection Recalled Due to Sterility Concerns

    First Royal Care Compounding Pharmacy is recalling Hydroxyprogesterone Caproate 250 mg/mL oil injection due to lack of assurance of sterility identified during FDA inspection. The drug was distributed to patients in seven states.

    Product
    HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0065-2022·2021-11-03

    MIT/B12 Compounded Injection Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling MIT/B12 25/50/50MG/ML 1MG/ML multidose vials due to FDA inspection findings that raised concerns about the lack of assurance of sterility. The product was distributed to approximately 494 patients across seven states.

    Product
    MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0053-2022·2021-11-03

    Acetylcysteine 10% ophthalmic solution recalled for sterility assurance concerns

    Red Mountain Compounding Pharmacy is recalling Acetylcysteine 10% ophthalmic solution due to lack of sterility assurance identified during an FDA inspection. Approximately 494 patients received prescriptions for the product across seven states.

    Product
    ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0030-2022·2021-11-03

    Levocarnitine 100mg/mL Solution Recall Due to Sterility Assurance

    Red Mountain Compounding Pharmacy is recalling Levocarnitine 100mg/mL solution for injection because FDA inspection found concerns about the product's sterility assurance. The product was distributed to patients in seven states.

    Product
    LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0037-2022·2021-11-03

    Estradiol Valerate Injection Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling Estradiol Valerate 5mg/mL injectable medication due to FDA inspection findings of inadequate sterility assurance. The product was distributed to approximately 494 patients across seven states.

    Product
    ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0048-2022·2021-11-03

    Compounded Anabolic Steroid Product Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling a compounded anabolic steroid product due to FDA concerns about sterility assurance identified during inspection. The product was distributed to approximately 494 patients in seven states.

    Product
    TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0066-2022·2021-11-03

    Progesterone 100mg/ml Oil Injection Recall: Sterility Assurance Defect

    Red Mountain Compounding Pharmacy is recalling Progesterone 100mg/ml MDV Oil Injection due to lack of assurance of sterility following FDA inspection. About 494 patients in seven states received prescriptions for this affected product.

    Product
    PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states