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.

24601–24625 of 32189

  • SevereFDA (Drugs)·D-0186-2015·2014-11-12

    FDA Recalls Dexpantenol Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Dexpantenol injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    DEXPANTHENOL with preservative, 250 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0224-2015·2014-11-12

    Testosterone Cypionate Injectable Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Testosterone Cypionate injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    TESTOSTERONE CYPIONATE (SESAME OIL/CMPD), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0219-2015·2014-11-12

    FDA Recalls Prednisolone Sodium Phosphate Eye Drops for Sterility Concerns

    Oregon Compounding Centers is recalling Prednisolone Sodium Phosphate ophthalmic drops due to quality control issues affecting sterility assurance.

    Product
    PREDNISOLONE Sodium Phosphate, 1%, Ophthalmic, 1 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0213-2015·2014-11-12

    FDA Recalls Papaverine Injection Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Papaverine HCL/Phentolamine Mes/Prostaglandin injections due to quality control issues affecting sterility assurance.

    Product
    PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0191-2015·2014-11-12

    Ganciclovir Syringes Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Ganciclovir syringes due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    GANCICLOVIR, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0176-2015·2014-11-12

    FDA Recalls Injectable Ascorbic Acid Vials Due to Sterility Concerns

    Oregon Compounding Centers is recalling injectable ascorbic acid vials because quality control issues observed during an FDA inspection present a potential risk to sterility assurance.

    Product
    ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0222-2015·2014-11-12

    Sodium Chloride Inhalation Solution Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Sodium Chloride Inhalation 7% solution due to quality control issues affecting sterility assurance.

    Product
    SODIUM CHLORIDE INHALATION, 7%, Solution for inhalation, 3 mL plastic vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·14V722000·2014-11-10

    Kenworth Heavy Trucks Recalled for Undersized Wire Gauge Fire Risk

    PACCAR is recalling 2015 Kenworth heavy trucks because an undersized wire in the instrument panel harness may overheat, increasing the risk of a vehicle fire.

    Product
    KENWORTH — KENWORTH T800, W900, T660, C500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V717000·2014-11-10

    Daimler Recalls 2014-2015 Freightliner Trucks Due to Brake Valve Defect

    Daimler is recalling 2014-2015 Freightliner trucks because defective air brake valves may reduce braking performance and increase crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER 122SD, ARGOSY, CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V719000·2014-11-10

    GM Recalls 2015 Trucks and SUVs for Power Steering Loss

    General Motors is recalling 2015 Chevrolet and GMC vehicles because a steering module defect may cause sudden loss of power assist, increasing crash risk.

    Product
    CHEVROLET — CHEVROLET, GMC SUBURBAN, YUKON, TAHOE, SILVERADO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V712000·2014-11-07

    Forest River Recalls 2015 Wildwood and Salem Trailers for Draw Bar Defect

    Forest River is recalling 2015 Wildwood and Salem Ice Cabin trailers because the draw bar may break, potentially causing the trailer to detach from the vehicle.

    Product
    FOREST RIVER — FOREST RIVER WILDWOOD, SALEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V716000·2014-11-07

    PACCAR Recalls Kenworth and Peterbilt Trucks Due to Brake Valve Defect

    PACCAR is recalling specific 2014-2015 Kenworth and Peterbilt trucks because defective parking brake valves may reduce braking performance and increase crash risk.

    Product
    KENWORTH — KENWORTH, PETERBILT K270, 220, K370, MODEL 220
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·076-2014·2014-11-06

    CS Best Food Recalls Pork Sausage Links Due To Undeclared Allergens

    CS Best Food Inc. is recalling pork sausage links containing undeclared wheat and soy allergens. The products were distributed in California and Washington.

    Product
    CS Best Food, Inc. — California Firm Recalls Pork Products Due To Misbranding And Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0071-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Cromolyn Sodium Inhalant Solution

    Martin Avenue Pharmacy is voluntarily recalling Cromolyn sodium 1% inhalant solution due to sterility assurance concerns identified during an FDA inspection.

    Product
    Cromolyn sodium 1% inhalant solution packaged in a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0085-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Hyaluronidase base vehicle, due to quality control issues affecting sterility assurance.

    Product
    Hyaluronidase base vehicle (PF) solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0111-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including PGE 1, due to quality control observations that risk sterility assurance.

    Product
    PGE 1, 40 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0137-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.

    Product
    Tacrolimus oil 0.03% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0058-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Atropine Sulfate Eye Drops for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Atropine sulfate 0.01% ophthalmic solution due to quality control issues that may compromise sterility.

    Product
    Atropine sulfate 0.01% opthalmic solution packaged in a squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V702000·2014-11-05

    Wabash National Van Trailer Recall for Cracking Pivot Bolts

    Wabash is recalling 2013 Van trailers because certain pivot bolts may crack, potentially causing the axle to separate and increasing crash risk.

    Product
    WABASH NATIONAL — WABASH NATIONAL VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0088-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including hydromorphone/clonidine/bupivacaine, due to quality control observations that risk sterility assurance.

    Product
    Hydromorphone/clonidine/bupivacaine 12 mg/600 mcg/0.2 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0130-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Quad Mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Quad Mix injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Quad mix, 9 mg/1 mg/10 mcg/0.1 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0119-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Phenylephrine Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Phenylephrine 1% injectable vials because quality control issues may compromise sterility assurance.

    Product
    Phenylephrine 1% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0091-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Hydromorphone and Bupivacaine Injections

    Martin Avenue Pharmacy is voluntarily recalling compounded hydromorphone and bupivacaine injections due to quality control issues that may compromise sterility.

    Product
    Hydromorphone HCl/bupivacaine (PF) 10 mg/7.5 mg/mL injection packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0096-2015·2014-11-05

    Hospira Recalls GemStar Power Supply Due to Power Delivery Failure

    Hospira is recalling GemStar Power Supplies because they may fail to provide direct current power to the infusion pump, potentially causing smoke.

    Product
    The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.
    Category
    Medical Device
    Distribution
    49 states