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.

10876–10900 of 29159

  • SevereFDA (Devices)·Z-0277-2020·2019-11-13

    Baxter Prismaflex Control Unit Recalled for Potential Therapy Interruption

    Baxter Healthcare is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.

    Product
    Prismaflex Control Unit, software versions below 7.21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0177-2020·2019-11-13

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

    Dr. Reddy's Laboratories is recalling specific bottles of Ranitidine Tablets 150 mg because an NDMA impurity was detected.

    Product
    Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison) OTC.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0168-2020·2019-11-13

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

    Dr. Reddy's is recalling Ranitidine Hydrochloride capsules because of the presence of the NDMA impurity.

    Product
    RANITIDINE HYDROCHLORIDE — RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0173-2020·2019-11-13

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

    Dr. Reddy's Laboratories is recalling CVS brand Ranitidine Tablets 75 mg because of the presence of NDMA impurity.

    Product
    Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80 count bottles (NDC 69842-871-80) c.)160 count bottles (NDC 69842-871-37) (CVS) OTC
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0289-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-Test Cyp/Prop/Deca-Nan Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Test Cyp/Prop/Deca-Nan 250mg/ml vials because the FDA determined there is a lack of assurance of sterility.

    Product
    S-TEST CYP/PROP/DECA-NAN 250MG/ML (80/10/10) IN SESAME OIL, Rx only, Rx Only, 10ml 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-0242-2020·2019-11-13

    Red Mountain Compounding Recalls S-Nandrolone Decanoate Injections for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Nandrolone Decanoate injections due to a lack of assurance of sterility. The affected lot is distributed nationwide.

    Product
    S-NANDROLONE DEC 200MG/ML MDV INJ in SESAME OIL, Rx Only, 10ml glass vial. Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0349-2020·2019-11-13

    ICU Medical Recalls Lactated Ringer's Injection Due to Particulate Matter

    ICU Medical is recalling 389,808 bags of Lactated Ringer's Injection due to the presence of particulate matter. The affected product was distributed nationwide.

    Product
    LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0271-2020·2019-11-13

    Red Mountain Compounding Recalls S-Methylcobalamin Injections for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Methylcobalamin injections due to a lack of assurance of sterility. The affected vials were distributed nationwide.

    Product
    S-METHYLCOBALAMIN 10,000MCG/ML MDV INJ; 30ML glass vial, Rx Only, Red Mountain Compounding Rx
    Category
    Drug
    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-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-0247-2020·2019-11-13

    Red Mountain Compounding Recalls S-Pyridoxine HCL Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Pyridoxine HCL (B6) vials because the product lacks assurance of sterility.

    Product
    S-PYRIDOXINE HCL (B6) 100MG/ML MDV, Rx Only, 30ml glass vial. Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0274-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-MIC/B12/Carnitine Injection for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-MIC/B12(C)/Carnitine injection due to a lack of assurance of sterility. The product was distributed nationwide in the USA.

    Product
    S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Lot #: S07172019DT@10, Exp 1/17/20; S02142019DH@01, Exp 8/14/19; S03192019DT@04,Exp 9/19/19; " S04162019DT@15, Exp 10/16/19; S07232019DH@04, Exp 1/23/20; S02142019DH@01, Exp 8/14/19; S04162019DT@15, Exp 9/9/19; s0709
    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-0185-2020·2019-11-13

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

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

    Product
    Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0198-2020·2019-11-13

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

    Red Mountain Compounding Pharmacy is recalling S-Amitriptyline 10mg/mL injection vials because the FDA determined there is a lack of assurance of sterility.

    Product
    S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0182-2020·2019-11-13

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

    Dr. Reddy's is recalling Ranitidine Tablets because an NDMA impurity was detected. Consumers should stop using the product and return it to the pharmacy.

    Product
    RANITIDINE — RANITIDINE (RANITIDINE)
    Category
    Drug
    Distribution
    0 states