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.

10901–10925 of 29159

  • SevereFDA (Drugs)·D-0296-2020·2019-11-13

    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. The recall covers specific lots distributed nationwide.

    Product
    S-TRIMIX (29.4MG/0.98MG/9.8MCG/ML) INJ; Rx Only, 5ml glass vial. Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0262-2020·2019-11-13

    Red Mountain Compounding Recalls S-Estradiol Cypionate Injections Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Estradiol Cypionate injections because the FDA identified a lack of assurance of sterility.

    Product
    S-ESTRADIOL CYP 5MG/ML MDV INJ IN SESAME OIL, packaged in a) 5ml, b) 10ml, c) 11ml, glass vials, Rx Only, Red Mountain Compounding RX.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0178-2020·2019-11-13

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

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 75 mg because of the presence of NDMA impurity. The product was distributed to major distributors throughout the United States.

    Product
    Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0257-2020·2019-11-13

    Red Mountain Compounding Recalls Vitamin D3 Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of Vitamin D3 10,000 IU/mL oil injection due to a lack of assurance of sterility.

    Product
    S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0238-2020·2019-11-13

    Red Mountain Compounding Recalls Magnesium Sulfate Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific vials of Magnesium Sulfate Injection because the FDA determined there is a lack of assurance of sterility.

    Product
    S-MAGNESIUM SULFATE 500MG/ML (4MEQ/ML) MDV INJ SOLN, 30 ML vial, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0175-2020·2019-11-13

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

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 75 mg because the presence of the NDMA impurity was detected in the product.

    Product
    Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) 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-0207-2020·2019-11-13

    Red Mountain Compounding Recalls Calcium Gluconate Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Calcium Gluconate 10% Injection due to a lack of assurance of sterility.

    Product
    S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass vials, 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-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 (Food)·F-0100-2020·2019-11-13

    Cellect and Essentials Factor Multi-Mineral Supplement Recalled for Arsenic and Lead

    Images Unlimited Products is recalling Cellect and Essentials Factor multi-mineral supplements due to unsafe levels of arsenic and lead.

    Product
    CELLECT brand and ESSENTIALS FACTOR Cell Synergy brand Unflavored Powdered Mix Multi-Mineral & Vitamin Supplement NET WT. Approximately 20.4 OZ (1.28 LB) 579g in white plastic bottles
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0224-2020·2019-11-13

    Red Mountain Compounding Recalls S-Glutathione Vials Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Glutathione 200mg/mL vials due to a lack of assurance of sterility.

    Product
    S-GLUTATHIONE 200MG/ML MDV, packaged in a) 12 ML b) 30 ml, glass vial, Red Mountain Compounding RX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0292-2020·2019-11-13

    Red Mountain Compounding Recalls S-Testosterone Ultra Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Testosterone Ultra 250mg/ml vials because the product lacks assurance of sterility.

    Product
    S-TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL (TEST CYP 200MG/TEST PROP 25MG/NANDROLONE DECA 25MG) Rx Only, 10ml glass vial Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0213-2020·2019-11-13

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

    Red Mountain Compounding Pharmacy is recalling S-DMPS 50mg/ml injection vials because the FDA identified a lack of assurance of sterility.

    Product
    S-DMPS 50MG/ML INJ SOLN (PF), 5 ml glass vial, Rx Only, 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-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 (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-0218-2020·2019-11-13

    Red Mountain Compounding Recalls S-Estradiol Cypionate Injections for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Estradiol Cypionate injections due to a lack of assurance of sterility.

    Product
    S-ESTRADIOL CYP 5MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10 ml, glass vials, Rx Only, Red Mountain Compounding RX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0244-2020·2019-11-13

    Red Mountain Compounding Recalls Potassium Chloride Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of Potassium Chloride Injection because the FDA identified a lack of assurance of sterility.

    Product
    S-POTASSIUM CHLORIDE 2 MEQ/ML INJECTION CONC (PF) 5ml glass vial, Rx Only Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide