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.

15301–15325 of 29202

  • SevereFDA (Drugs)·D-0025-2018·2017-11-01

    Banner Pharmacy Recalls Succinylcholine Syringes Due to Sterility Concerns

    Banner Pharmacy Services is recalling 2,792 syringes of Succinylcholine 200 mg/10 mL because the product lacks assurance of sterility.

    Product
    Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025088801
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0035-2018·2017-11-01

    Weis Markets Recalls BLT Sandwiches Due to Undeclared Egg Allergen

    Weis Markets is recalling store-made BLT sandwiches because the mayonnaise contains undeclared egg. The recall follows a consumer complaint regarding the missing allergen label.

    Product
    Weis, Sunbury, PA; BLT Sandwich; 1 CT
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0039-2018·2017-11-01

    Great American Deli Recalls Chicken Salad Sandwiches for Undeclared Allergens

    Great American Deli is recalling 816 chicken salad sandwiches because they contain undeclared eggs and soy. The product was distributed in Michigan, Kentucky, Tennessee, and Georgia.

    Product
    GREAT AMERICAN DELI PREMIUM CHICKEN SALAD WHEATBERRRY sandwiches are packaged in a flexible plastic containers, NET WT. 6.4 oz (181g), Great American Deli, PO Box 27, Ooltewah, TN 37363 UPC 7 41431 00228 6
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0016-2018·2017-11-01

    Banner Pharmacy Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    Banner Pharmacy Services is recalling ephedrine sulfate syringes because the company cannot ensure the product is sterile.

    Product
    ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025024801
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0022-2018·2017-11-01

    Banner Pharmacy Recalls Norepinephrine Bags Due to Sterility Concerns

    Banner Pharmacy Services is recalling 3,550 bags of Norepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride due to a lack of assurance of sterility.

    Product
    Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011501
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0042-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 534 bags of compounded Oxytocin 30 units in 1000 mL bags because the drug was found to be subpotent.

    Product
    Oxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-242-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0048-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 90 bags of compounded Oxytocin 40 units in Lactated Ringer's because the drug was subpotent.

    Product
    Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-245-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0027-2018·2017-11-01

    Banner Health Recalls Vancomycin Bags Due to Sterility Concerns

    Banner Pharmacy Services is recalling 2,443 bags of Vancomycin in sodium chloride due to a lack of assurance of sterility.

    Product
    VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025007001
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0044-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide

    Pharmedium Services is recalling 6,108 bags of compounded Oxytocin 30 units in Lactated Ringer's because the drug was subpotent. The recall is voluntary and nationwide.

    Product
    Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-243-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0021-2018·2017-11-01

    Banner Pharmacy Recalls Midazolam Cassettes Due to Sterility Concerns

    Banner Pharmacy Services is recalling 966 cassettes of Midazolam HCL 100 mg due to a lack of assurance of sterility. The affected products were distributed nationwide.

    Product
    Midazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025016201
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0036-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide

    Pharmedium Services, LLC is recalling 1,308 bags of compounded Oxytocin 10 units in Lactated Ringer's Injection because the drug was subpotent.

    Product
    Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag ,Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-237-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0035-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 564 bags of compounded Oxytocin 10 units in Lactated Ringer's Injection because the drug was subpotent.

    Product
    Oxytocin 10 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-237-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0047-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 24,486 bags of compounded Oxytocin 30 units in Lactated Ringer's because the drug was subpotent.

    Product
    Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-243-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0020-2018·2017-11-01

    Banner Pharmacy Recalls Magnesium Sulfate IV Bags Due to Sterility Concerns

    Banner Pharmacy Services is recalling 7,578 bags of Magnesium sulfate 10 Gm in Lactated Ringer's due to a lack of assurance of sterility.

    Product
    Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025003201
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0015-2018·2017-11-01

    Banner Pharmacy Recalls Diltiazem HCL Bags Due to Sterility Concerns

    Banner Pharmacy Services is recalling 1,359 bags of Diltiazem HCL 125 mg in 0.9% Sodium Chloride due to a lack of assurance of sterility.

    Product
    Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025018601
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0021-2018·2017-11-01

    OriGen Reinforced Dual Lumen Catheter Recalled for Tube Separation

    OriGen Biomedical is recalling 180 units of Reinforced Dual Lumen Catheters because the extension tube may separate from the hub, causing patient injury.

    Product
    The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0024-2018·2017-11-01

    Banner Pharmacy Recalls Ropivacaine HCL Cassettes Due to Sterility Concerns

    Banner Pharmacy Services is recalling Ropivacaine HCL cassettes because the FDA determined there is a lack of assurance of sterility.

    Product
    Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226 NDC 7025006301
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0043-2018·2017-11-01

    MicroPort Orthopedics Recalls 48 Schanz Screws Due to Seal Defect

    MicroPort Orthopedics is recalling 48 sterile Schanz screws due to an inadequate pouch seal that could compromise sterility and lead to infection.

    Product
    MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0041-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 60 bags of compounded Oxytocin injection because the drug was found to be subpotent.

    Product
    Oxytocin 20 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0017-2018·2017-11-01

    Fentanyl Citrate Infusion Cassettes Recalled for Sterility Assurance Concerns

    Banner Pharmacy Services is recalling fentanyl citrate infusion cassettes due to a lack of assurance of sterility. The affected products were distributed nationwide.

    Product
    fentaNYL citrate 1000 mcg (10 mcg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025011001
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0049-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide

    Pharmedium Services is voluntarily recalling 42 bags of compounded Oxytocin 40 units in Lactated Ringer's solution because the drug was subpotent.

    Product
    Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-245-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0043-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 4,452 bags of compounded Oxytocin 30 units due to subpotent drug levels. The FDA classified this as a Class II recall.

    Product
    Oxytocin 30 units added to 500 mL 5% Dextrose/Lactated Ringer's USP in 500 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-242-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0019-2018·2017-11-01

    FDA Recalls Hydromorphone Syringes Due to Sterility Concerns

    Banner Pharmacy Services is recalling specific lots of Hydromorphone HCl syringes because the FDA determined there is a lack of assurance of sterility.

    Product
    Hydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025001001.
    Category
    Drug
    Distribution
    Distributed nationwide