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.

10801–10825 of 29159

  • SevereNHTSA·19V814000·2019-11-14

    GM Recalls 2019-2020 Silverado and Sierra Trucks for Fire Risk

    General Motors is recalling specific 2019-2020 Chevrolet Silverado and GMC Sierra trucks because hot gas from seat belt pretensioners could ignite the carpet, causing a vehicle fire.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 1500, SILVERADO 2500, SILVERADO 3500, SIERRA 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0216-2020·2019-11-13

    Philips Forte Gamma Camera System Recalled for Falling Detector Hazard

    Philips Medical Systems is recalling 1,167 Forte Gamma Camera Systems because a detector may fall vertically to the end stops of its travel limit.

    Product
    Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0345-2020·2019-11-13

    Abiomed lmpella CP Pump Recalled for Incorrect Programming and Disabled Alarms

    Abiomed is recalling one lmpella CP pump with Smart Assist due to incorrect programming that disabled safety alarms and altered pump operation.

    Product
    lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0291-2020·2019-11-13

    Red Mountain Compounding Recalls Testosterone Propionate Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of Testosterone Propionate 100mg/mL in sesame oil because the product lacks assurance of sterility.

    Product
    S-TESTOSTERONE PROPIONATE 100MG/ML MDV IN SESAME OIL, Rx Only, 5ML glass vial, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0297-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-TRIMIX Injections for Sterility Concerns

    First Royal Care Co. LLC is recalling S-TRIMIX compounded injections nationwide due to a lack of assurance of sterility.

    Product
    S-TRIMIX various strengths to include:a) S-TRIMIX (15MG/1MG/10MCG/ML) MDV: b) S-TRIMIX (18MG/0.6MG/6MCG/ML) MDV INJ: c) S-TRIMIX (24MG/0.89MG/8.9MCG/ML) MDV INJ: d) S-TRIMIX (28.85MG/1.9MG/19.2MCG/ML) MDV: e) S-TRIMIX (30MG/1MG/10MCG/ML) MDV: f) S-TRIMIX (30MG/2MG/25MCG/ML) MDV:
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0294-2020·2019-11-13

    Red Mountain Compounding Recalls S-TRIMIX Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-TRIMIX injection vials because the product lacks assurance of sterility.

    Product
    S-TRIMIX (15MG/0.5MG/16MCG/ML) INJ, Rx Only, 5ML glass vial. Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0248-2020·2019-11-13

    Red Mountain Compounding Recalls S-QUADMIX Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-QUADMIX injection vials because the product lacks assurance of sterility.

    Product
    S-QUADMIX (30MG/2MG/20MCG/0.15MG/ML) MDV INJ, Rx Only, 5ml Glass vial. Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0179-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because of the presence of NDMA impurity. The product was distributed to major distributors throughout the United States.

    Product
    Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0276-2020·2019-11-13

    Red Mountain Compounding Recalls S-MIC 25/50/50 B12A Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-MIC 25/50/50 B12A 5mg/ml solution due to a lack of assurance of sterility.

    Product
    S-MIC 25/50/50 B12A 5MG/ML MDV SOLN; Rx Only, 30ml Glass vial, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0245-2020·2019-11-13

    Red Mountain Compounding Recalls S-Procaine HCL 1% Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Procaine HCL 1% Buffered MDV vials because the FDA determined there is a lack of assurance of sterility.

    Product
    S-PROCAINE HCL 1% BUFFERED MDV; Rx Only, 30ml glass vial Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0290-2020·2019-11-13

    Red Mountain Compounding Recalls Sterility-Compromised CYP/PROP Vials

    Red Mountain Compounding Pharmacy is recalling specific lots of S-TEST CYP/PROP 160/40MG/ML MDV in sesame oil due to a lack of assurance of sterility.

    Product
    S-TEST CYP/PROP 160/40MG/ML MDV IN SESAME OIL; Rx Only, a) 10ml b) 13 ml glass vials, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0233-2020·2019-11-13

    Red Mountain Compounding Recalls Lidocaine Syringes Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Lidocaine HCL 2% inhalation solution syringes due to a lack of assurance of sterility.

    Product
    S-LIDOCAINE HCL 2% INHALATION SOLN SYRINGES, 2ML syringe, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0275-2020·2019-11-13

    Red Mountain Compounding Recalls S-MIC Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-MIC 25/50/50mg/mL B12 1mg/mL MDV Injection Solution vials because of a lack of assurance of sterility.

    Product
    S-MIC 25/50/50MG/ML B12A1MG/ML MDV INJ SOLN; Rx Only, a) 10ML b) 30ML glass vial. Red Mountain Compounding RX.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0221-2020·2019-11-13

    Red Mountain Compounding Recalls Ophthalmic Gel Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling a specific lot of ophthalmic gel because the FDA determined there is a lack of assurance of sterility.

    Product
    S-GAT/KLAC/LIDO/PHE/TPMD 0.036/0.036/1.42/0.71/0.071%, OPTH GEL, 5ML dropper bottle, Red Mountain Compounding RX.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0170-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because the presence of the NDMA impurity was detected in the product.

    Product
    Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) 65 count bottles (NDC 0363-0010-61) , c.) 95 count bottles (NDC 0363-0010-62), d.) 200 count bottles (NDC 0363-0010-01) (Walgreens) OTC
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0176-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because the presence of the NDMA impurity was detected in the product.

    Product
    Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0234-2020·2019-11-13

    Red Mountain Compounding Recalls Lidocaine Vials Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Lidocaine HCl 1% vials because the FDA identified a lack of assurance of sterility.

    Product
    S-LIDOCAINE HCL 1% MDV SOLN, 50ML Vial, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0281-2020·2019-11-13

    GE Healthcare Recalls Giraffe OmniBed Carestation CS1 Due to Fastener Risk

    GE Healthcare is recalling 59 Giraffe OmniBed Carestation CS1 devices because fasteners may be under-torqued, posing a risk that the canopy could detach and fall.

    Product
    Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled man
    Category
    Medical Device
    Distribution
    Distributed nationwide