The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

22926–22950 of 32171

  • SevereFDA (Drugs)·D-0999-2015·2015-05-20

    Health Innovations Pharmacy Recalls HCG Injection Due to Sterility Concerns

    Health Innovations Pharmacy is recalling HCG 1000 Units/mL Injection because inspection findings raised concerns about sterility and stability data.

    Product
    HCG 1000 Units/mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-2207-2015·2015-05-20

    Cleveland Crops Recalls Chili Cheezy Kale Chips Due to Undeclared Cashews

    Cleveland Crops Food Innovation Center is recalling Chili Cheezy Kale Chips because the ingredient list failed to declare raw cashews. The product was distributed in Ohio.

    Product
    Cleveland Crops Chili Cheezy Kale Chips Made with 100% Dehydrated Raw Kale, Raw, Gluten Free, Vegan, No Preservatives FRESH PRODUCE NO SUGAR ADDED CUYAHOGA COUNTY Board of Developmental Disabilities INGREDIENTS Raw Dehydrated Kale, Tomatoes, Lemon Juice, Chili Powder, Garlic…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1002-2015·2015-05-20

    Sodium Tetradecyl 1% Injection Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Sodium Tetradecyl 1% Injection due to inspection findings regarding sterility and stability data.

    Product
    Sodium Tetradecyl 1% Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1071-2015·2015-05-20

    Fallon Wellness Pharmacy Recalls Papaverine Injection Due to Sterility Concerns

    Fallon Wellness Pharmacy is recalling 6 vials of Papaverine/phentolamine/prostaglandin injection in New York due to a lack of assurance of sterility.

    Product
    Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1033-2015·2015-05-20

    Health Innovations Pharmacy Recalls Pyrimethamine Suspension Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Pyrimethamine 2 mg/1 mL Suspension because inspection findings raised concerns about sterility and stability data.

    Product
    Pyrimethamine 2 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D1051-2015·2015-05-20

    Health Innovations Pharmacy Recalls Qsymia Capsules Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Qsymia capsules due to inspection findings regarding sterility and stability data.

    Product
    Phen 15 mg - Topri 92 mg SR Cap (Qsymia), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0998-2015·2015-05-20

    Health Innovations Pharmacy Recalls 17-HP Hydroxyprogesterone Injection Due to Sterility Concerns

    Health Innovations Pharmacy is recalling 17-HP Hydroxyprogesterone 250mg/1ml Injection because inspection findings indicate a lack of assurance regarding sterility and stability data.

    Product
    17-HP Hydroxyprogesterone 250mg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1038-2015·2015-05-20

    Health Innovations Pharmacy Recalls Rifampin Suspension Due to Sterility Concerns

    Health Innovations Pharmacy is recalling all lots of Rifampin 25 mg/1 mL Suspension due to inspection findings regarding sterility and stability data.

    Product
    Rifampin 25 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1054-2015·2015-05-20

    Health Innovations Pharmacy Recalls Methenamine Capsules Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Methenamine/Phenyl Salicylate Capsules due to quality control issues that may affect sterility and stability.

    Product
    Methenamine/Phenyl Salicylate Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·15V301000·2015-05-20

    Honda Recalls 2014-2015 Acura Vehicles for Braking System Defect

    Honda is recalling 2014-2015 Acura MDX, RLX, and RLX Hybrid vehicles because the Collision Mitigation Braking System may unexpectedly apply brakes, increasing crash risk.

    Product
    ACURA — ACURA RLX, RLX HYBRID, MDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2284-2015·2015-05-20

    Texas Star Nut and Food Co. Recalls Macadamia Nuts for Salmonella

    Texas Star Nut and Food Co. is recalling specific lots of Nature's Eats and Central Market macadamia nuts because they tested positive for Salmonella.

    Product
    Nature's Eats Natural Macadamia Nuts NET WT 6 oz. (170g) in clear cello bags, UPC: 8-32112-00912-7; Central Market Macadamia Nuts NET WT 6 oz. (170g) in clear cello bags, UPC: 8-32112-00820-5
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1030-2015·2015-05-20

    Health Innovations Pharmacy Recalls Nitroglycerin Cream Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Nitroglycerin 0.2% Compounded Cream because inspection findings indicate a lack of assurance regarding sterility and stability data.

    Product
    Nitroglycerin 0.2% Compd Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1024-2015·2015-05-20

    Baclofen Suspension Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Baclofen 20 mg/4 mL Suspension due to inspection findings regarding sterility and stability data.

    Product
    Baclofen 20 mg/4 mL Susp., Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1035-2015·2015-05-20

    Nadolol 10 mg/1 mL Suspension Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Nadolol 10 mg/1 mL Suspension due to lack of assurance of sterility and stability data supporting the expiry date.

    Product
    Nadolol 10 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1052-2015·2015-05-20

    Ciprodex with Amphoteracin B Ear Drops Recalled for Sterility Concerns

    Health Innovations Pharmacy is recalling Ciprodex with Amphoteracin B ear drops due to lack of assurance of sterility and stability data.

    Product
    Ciprodex with Amphoteracin B (ear drops), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1006-2015·2015-05-20

    Health Innovations Pharmacy Recalls Fortifed Tobramycin Ophthalmic Solution

    Health Innovations Pharmacy is recalling Fortifed Tobramycin 15 mg/1 mL ophthalmic solution due to lack of assurance of sterility and stability data.

    Product
    Fortifed Tobramycin 15 mg/1 mL Opth., Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1021-2015·2015-05-20

    Health Innovations Pharmacy Recalls BLT New Formula Sample Due to Sterility Concerns

    Health Innovations Pharmacy is recalling BLT New Formula 20%/7%/7% samples because inspection observations indicate a lack of assurance regarding sterility and stability data.

    Product
    BLT New Formula 20%/7%/7% Sample, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1604-2015·2015-05-20

    HeartWare HVAD Pump Driveline Splice Kit Recalled for Failure Risk

    HeartWare Inc is recalling HVAD Pump Driveline Splice Kits because they may fail if exposed to excessive force. The recall affects 35 units distributed in the US and several international countries.

    Product
    HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V298000·2015-05-20

    Starcraft Transit Buses Recalled for Potential Fire Risk

    Starcraft is recalling 2006-2015 transit buses because a loose electrical connection may cause overheating and fire.

    Product
    STARCRAFT — STARCRAFT ALLSTAR, STARLITE, SENATOR II, STARQUEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1070-2015·2015-05-20

    Fallon Wellness Pharmacy Recalls Papaverine Injection Due to Sterility Concerns

    Fallon Wellness Pharmacy is recalling 8 vials of Papaverine/phentolamine/prostaglandin injection in New York due to a lack of assurance of sterility.

    Product
    Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1042-2015·2015-05-20

    Health Innovations Pharmacy Recalls Fortified Vancomycin Opth Drops

    Health Innovations Pharmacy is recalling Fortified Vancomycin 25 mg/1 mL Opth Drops due to quality control issues affecting sterility and stability.

    Product
    Fortified Vancomycin 25 mg/1 mL Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1029-2015·2015-05-20

    Health Innovations Pharmacy Recalls Warfarin Capsules Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Warfarin 2.5 ng Lactose Free Capsules due to inspection findings regarding sterility and stability data.

    Product
    Warfarin 2.5 ng Lactose Free Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1074-2015·2015-05-20

    Fallon Wellness Pharmacy Recalls Methylcobolamin Injections Due to Sterility Concerns

    Fallon Wellness Pharmacy is recalling 56 vials of Methylcobolamin injections in New York due to a lack of assurance of sterility.

    Product
    Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/0.04mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1053-2015·2015-05-20

    Health Innovations Pharmacy Recalls DNCB 0.3% Ointment for Sterility Concerns

    Health Innovations Pharmacy is recalling DNCB 0.3% Ointment due to lack of assurance of sterility and stability data. The recall covers all lots distributed in North Carolina.

    Product
    DNCB 0.3% Ointment, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·15V294000·2015-05-19

    Blue Bird All American Buses Recalled for Engine Fire Risk

    Blue Bird is recalling 2009-2016 All American non-school buses due to a defect that may allow engine oil to contact hot surfaces, increasing fire risk.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide