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.

13351–13375 of 29186

  • SevereFDA (Drugs)·D-0180-2019·2018-11-07

    Pharm D Solutions Recalls Sermorelin/GHRP-2 Powder Due to Sterility Concerns

    Pharm D Solutions is recalling 409 vials of Sermorelin/GHRP-2 powder because the company cannot ensure the product is sterile.

    Product
    Sermorelin/GHRP-2 6 mg/6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1727-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0158-2019·2018-11-07

    Pharm D Solutions Recalls HCG Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling HCG Reconstitued 6000 IU Injectable vials because the company cannot ensure the product is sterile.

    Product
    HCG Reconstitued 6000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1739-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E102000·2018-11-07

    Eaton Recalls Heavy-Duty Truck Clutches Due to Component Failure Risk

    Eaton is recalling specific heavy-duty truck clutches because an internal component may fail, potentially causing unintended vehicle movement and increasing crash risk.

    Product
    POWER TRAIN:CLUTCH ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0192-2019·2018-11-07

    Pharm D Solutions Recalls Trimix BM3 Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable because the agency could not ensure the product was sterile.

    Product
    Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1310-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0174-2019·2018-11-07

    Pharm D Solutions Recalls Prostaglandin E1 Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Prostaglandin E1 40 mcg/mL Injectable because the agency cannot assure the product is sterile.

    Product
    Prostaglandin E1 40 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1347-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0148-2019·2018-11-07

    Pharm D Solutions Recalls Calcium Gluconate Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Calcium Gluconate 10% Injectable because the company cannot guarantee the product is sterile.

    Product
    Calcium Gluconate 10%, 100 mg/mL Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-0914-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0191-2019·2018-11-07

    Pharm D Solutions Recalls Tri-Mix Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling 609 vials of Tri-Mix Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC 69699-1332-05 b) (LYO) Powder NDC 69699-1332-05, Pharm D Solutions, Houston, Texas
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0298-2019·2018-11-07

    Siemens AXIOM Multix MT Patient Table Recalled for Cable Failure Risk

    Siemens is recalling 11 AXIOM Multix MT patient tables because steel cables may rupture, causing the arm to drop unexpectedly during patient positioning.

    Product
    AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the Siemens Multix PRO- and TOP Systems radiographic exposures of the entire body.
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Drugs)·D-0154-2019·2018-11-07

    Pharm D Solutions Recalls Glutathione Solution Due to Sterility Concerns

    Pharm D Solutions is recalling 4,000 mL of Glutathione 200 mg/mL Solution because the product lacks assurance of sterility.

    Product
    Glutathione 200 mg/mL Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1504-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0153-2019·2018-11-07

    Pharm D Solutions Recalls Glutamine Solution Due to Sterility Concerns

    Pharm D Solutions is recalling Glutamine 10 mg/mL Solution because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide.

    Product
    Glutamine 10 mg/mL Solution, Pharm D Solutions, Houston, Texas ---- NDC 69699-1439-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0200-2019·2018-11-07

    Pharm D Solutions Recalls Trimix Injection Due to Sterility Concerns

    Pharm D Solutions is recalling 815 vials of Trimix injection because the company cannot guarantee the product is sterile.

    Product
    Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1366-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0133-2019·2018-11-07

    Avella Recalls Hydromorphone Bags Due to Sterility Assurance Concerns

    Avella of Deer Valley, Inc. is recalling 360 bags of Hydromorphone in NS due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0168-2019·2018-11-07

    Pharm D Solutions Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Methylcobalamin 1 mg/mL injectable because the company cannot ensure the product is sterile.

    Product
    Methylcobalamin 1 mg/mL a) 10 mL Injectable NDC 69699-1501-10; b) 30 mL Injectable NDC 69699-1501-30, Pharm D Solutions, Houston, Texas
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0177-2019·2018-11-07

    Pharm D Solutions Recalls Atropine Solution Due to Sterility Concerns

    Pharm D Solutions is recalling QM-4A Quadmix Atropine 0.4 mg Aqueous Solution because there is a lack of assurance of sterility.

    Product
    QM-4A Quadmix 5 mL 30 PA-2PH-150A-Atropine 0.4 mg Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1342-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0182-2019·2018-11-07

    Pharm D Solutions Recalls Sermorelin/GHRP-2 Powder Due to Sterility Concerns

    Pharm D Solutions is recalling 330 vials of Sermorelin/GHRP-2 Powder because the company cannot ensure the product is sterile.

    Product
    Sermorelin/GHRP-2 9 mg-6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1728-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0123-2019·2018-11-07

    Sprayology Recalls Body Skin Tonic Due to Potential Microbial Contamination

    Sprayology is recalling Body Skin Tonic homeopathic oral spray because it was manufactured under conditions that could result in possible microbial contamination.

    Product
    Body Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0017-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0135-2019·2018-11-07

    Avella Recalls Phenylephrine Infusion Bags Due to Sterility Concerns

    Avella of Deer Valley is recalling 300 bags of Phenylephrine 30 mg in NS 250 mL due to a lack of assurance of sterility.

    Product
    Phenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0181-2019·2018-11-07

    Pharm D Solutions Recalls Sermorelin Powder Due to Sterility Concerns

    Pharm D Solutions is recalling 124 vials of Sermorelin/GHRP-2 powder nationwide because the company cannot ensure the product is sterile.

    Product
    Sermorelin/GHRP-2 18 mg/6 mg powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1748-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0339-2019·2018-11-07

    Feel Good Foods Recalls Vegetable Fried Rice for Undeclared Egg

    Feel Good Foods Inc is recalling frozen Vegetable Fried Rice because it contains undeclared egg. The product was distributed in six states.

    Product
    feel good foods VEGETABLE FRIED RICE NET WT 9 OZ (255G), UPC: 8 99039 00212 9. Frozen.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0137-2019·2018-11-07

    Pharm D Solutions Recalls Arginine Injections Due to Sterility Concerns

    Pharm D Solutions is recalling Arginine Injections 100 mcg/mL due to a lack of assurance of sterility. The affected lots were distributed nationwide.

    Product
    Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0151-2019·2018-11-07

    Pharm D Solutions Recalls Epi-Shugarcaine Kit Due to Sterility Concerns

    Pharm D Solutions is recalling 70 bottles of Epi-Shugarcaine Kit Solution because the company cannot ensure the product is sterile.

    Product
    Epi-Shugarcaine Kit Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1409-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0289-2019·2018-11-07

    Stryker Recalls Hoffman LRF Hexapod Struts Due to Pin Displacement Risk

    Stryker GmbH is recalling 832 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising the stability of the orthopedic frame.

    Product
    Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0214-2019·2018-11-07

    Pharm D Solutions Recalls Testosterone Cypionate/Proprinate Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable because of a lack of assurance of sterility.

    Product
    Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1745-30
    Category
    Drug
    Distribution
    Distributed nationwide