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.

10851–10875 of 29159

  • SevereFDA (Drugs)·D-0251-2020·2019-11-13

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

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Taurine 50mg/ml vials because the FDA determined there is a lack of assurance of sterility.

    Product
    S-TAURINE 50MG/ML MDV SOLN, Rx only 30ml glass vial, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0219-2020·2019-11-13

    Red Mountain Compounding Recalls S-Estradiol Valerate Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Estradiol Valerate 20mg/mL injection vials because the product lacks assurance of sterility.

    Product
    S-ESTRADIOL VALERATE 20MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0123-2020·2019-11-13

    Jumbo Foods Recalls Tuscan Sun Chipotle Chicken Salad Sandwiches

    Jumbo Foods is recalling Tuscan Sun brand Chipotle Chicken Salad sandwiches due to a potential for contamination with Listeria monocytogenes.

    Product
    Chipotle Chicken Salad, Tuscan Sun brand, is a ready to eat sandwich. Net wt. 9.3 oz (263g). UPC 0 43701 01415 0. Product was distributed frozen or refrigerated (fresh) to stores. Frozen product is not sold directly to consumers and it will be thawed by stores prior selling
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0180-2020·2019-11-13

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

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

    Product
    RANITIDINE HYDROCHLORIDE — RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0255-2020·2019-11-13

    Red Mountain Compounding Recalls S-Vit B Complex Injection for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Vit B Complex Injection vials due to a lack of assurance of sterility. The product was distributed nationwide in the USA.

    Product
    S-VIT B COMPLEX (1/3/5/6/12A) MDV INJ 100/2/2/100/1MG/ML, 30 ML glass vial. Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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 (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-0174-2020·2019-11-13

    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 the NDMA impurity.

    Product
    Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0203-2020·2019-11-13

    Red Mountain Compounding Recalls S-Atropine 0.5% Ophthalmic Solution

    Red Mountain Compounding Pharmacy is recalling S-Atropine 0.5% ophthalmic solution due to a lack of assurance of sterility.

    Product
    S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, 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-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-0184-2020·2019-11-13

    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 the NDMA impurity.

    Product
    Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC
    Category
    Drug
    Distribution
    0 states
  • 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-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 (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-0209-2020·2019-11-13

    Red Mountain Compounding Recalls S-Cyanocobalamin Injections Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Cyanocobalamin 1,000 mcg/mL injection solution because the product lacks assurance of sterility.

    Product
    S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN, packaged in a) 10ml and b) 30 ml glass vial, Rx Only, 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-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