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.

13376–13400 of 29188

  • 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
  • SevereFDA (Drugs)·D-0213-2019·2018-11-07

    Pharm D Solutions Recalls Testosterone Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Testosterone in Grapeseed Oil Injectable because the product lacks assurance of sterility. The recall covers multiple vial sizes distributed nationwide.

    Product
    Testosterone in Grapeseed Oil 200 mg/mL, a) 4 mL, b) 5 mL, c) 10 mL and d) 30 mL Injectable, Pharm D Solutions, Houston, Texas NDC 69699-1702-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0118-2019·2018-11-07

    Sprayology Recalls Snore Soother Homeopathic Oral Spray Due to CGMP Deviations

    Sprayology is recalling Snore Soother Homeopathic Oral Spray because it was manufactured under conditions that could result in possible microbial contamination.

    Product
    Snore Soother, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0024-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0141-2019·2018-11-07

    Pharm D Solutions Recalls Bi-Mix Injection Due to Sterility Concerns

    Pharm D Solutions is recalling Bi-Mix Injection (Alprostadil/Lidocaine) because the company cannot ensure the product is sterile. The recall covers nationwide distribution.

    Product
    Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, Houston, Texas --- NDC 69699-1323-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0171-2019·2018-11-07

    Pharm D Solutions Recalls Phenol Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable due to a lack of assurance of sterility.

    Product
    Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1432-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0176-2019·2018-11-07

    Pharm D Solutions Recalls Pyridoxine Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Pyridoxine 100 mg/mL injectable vials due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Pyridoxine 100 mg/mL, 30 mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1614-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0206-2019·2018-11-07

    Pharm D Solutions Recalls Trimix Aqueous Solution Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Trimix aqueous solution because the agency could not ensure the product was sterile.

    Product
    Trimix ST9D 30PA-2PH-150A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1311-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0124-2019·2018-11-07

    Sprayology Recalls Acne Tonic Homeopathic Oral Spray Due to CGMP Deviations

    Sprayology is recalling 919 bottles of Acne Tonic Homeopathic Oral Spray because manufacturing conditions could result in possible microbial contamination.

    Product
    Acne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0027-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0144-2019·2018-11-07

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

    Pharm D Solutions is recalling 29 vials of Bi-Mix (Papaverine/Phentolamine) injectable and powder nationwide due to a lack of assurance of sterility.

    Product
    Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable NDC 69699-1760-15; b) (LYO) Powder NDC 69699-1760-15, Pharm D Solutions, Houston, Texas
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0183-2019·2018-11-07

    Pharm D Solutions Recalls Sermorelin Powder Due to Sterility Concerns

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

    Product
    Sermorelin/GHRP-2 9 mg/9 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1715-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0155-2019·2018-11-07

    Pharm D Solutions Recalls Glycerin Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Glycerin 72% Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Glycerin 72% (Lidocaine/Epi 2:1) Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1401-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0341-2019·2018-11-07

    SLR Food Recalls Sugar Melon Candy for Undeclared Sulfites

    SLR Food Distribution, Inc. is recalling Sugar Melon Candy / Wax Gourd because the product contains undeclared sulfites. The recall covers 30 cases distributed to six states.

    Product
    SUGAR MELON CANDY / WAX GOURD The product comes in a 7.04oz plastics package marked with barcode 6912567116718.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0209-2019·2018-11-07

    Pharm D Solutions Recalls Trimix Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Trimix T105 injectable solution because the company cannot ensure the product is sterile.

    Product
    Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D Solutions, Houston, Texas --- NDC 69699-1351-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0157-2019·2018-11-07

    Pharm D Solutions Recalls HCG Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling HCG Reconstitued 50,000 IU Injectable because the product lacks assurance of sterility.

    Product
    HCG Reconstitued 50,000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1736-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0211-2019·2018-11-07

    Pharm D Solutions Recalls Water for Injection Bags Due to Sterility Concerns

    Pharm D Solutions is recalling 12 bags of Water Sterile for Injection due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Water Sterile for Injection 250 mL IV Pharm D Solutions, Houston, Texas --- NDC 69699-1407-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0152-2019·2018-11-07

    Pharm D Solutions Recalls Epinephrine Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling 945 syringes of Epinephrine 1 mg/1 mL injectable solution nationwide due to a lack of assurance of sterility.

    Product
    Epinepherine 1 mg/1 mL 3 mL Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-0109-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0188-2019·2018-11-07

    Pharm D Solutions Recalls Sterile Water Bags Due to Sterility Concerns

    Pharm D Solutions is recalling 10 bags of Sterile Water 50 mL Aqueous Solution because the company cannot guarantee the product's sterility.

    Product
    Sterile Water 50 mL Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1421-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0207-2019·2018-11-07

    Pharm D Solutions Recalls Trimix T-101 Injection Due to Sterility Concerns

    Pharm D Solutions is recalling Trimix T-101 injection because the product may lack assurance of sterility.

    Product
    Trimix T-101 Alprostadil/Phapaverine/Phentolamine 5.9 mcg/17.65 mg/Phentolamine 0.59 mcg per mL Pharm D Solutions, Houston, Texas --- NDC 69699-1366-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0288-2019·2018-11-07

    Stryker Recalls Hoffmann LRF Hexapod Struts Due to Pin Fit Defect

    Stryker GmbH is recalling 578 Hoffmann 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 89mm-109mm, Model Number 4935-0-010. 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 (Devices)·Z-0286-2019·2018-11-07

    Zimmer Biomet Recalls OsteoGen Bone Growth Stimulators for Cleanliness Issues

    Zimmer Biomet is recalling 4,879 OsteoGen Implantable Bone Growth Stimulators because the company could not ensure product cleanliness parameters were consistently met.

    Product
    EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0189-2019·2018-11-07

    Pharm D Solutions Recalls Tilarginine Acetate Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Tilarginine Acetate 50 mg/mL injectable vials because the company cannot ensure the product is sterile.

    Product
    Tilarginine Acetate 50 mg/mL, 10 mL, Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1461-10
    Category
    Drug
    Distribution
    Distributed nationwide