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.

12826–12850 of 29186

  • SevereFDA (Drugs)·D-0447-2019·2019-02-20

    Promise Pharmacy Recalls Thymosin Beta-4 Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 94 vials of Thymosin Beta-4, 15 mg Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0449-2019·2019-02-20

    Promise Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 255 vials of Sermorelin 9 mg injection nationwide due to a lack of sterility assurance.

    Product
    Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0902-2019·2019-02-20

    Bundle Organics Chocolate-Maca Snack Bars Recalled for Mold Presence

    1908 Brands is recalling Bundle Organics Chocolate-Maca snack bars due to the presence of mold. The recall affects 2,534 bars distributed to one consignee.

    Product
    Bundle Organics Bar Chocolate-Maca, 1.9 Oz snack bar, Ambient storage
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0468-2019·2019-02-20

    Promise Pharmacy Recalls Nicotinamide Adenine Dinucleotide Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling specific lots of Nicotinamide Adenine Dinucleotide injections due to a lack of sterility assurance. The affected products were distributed nationwide in the USA.

    Product
    Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0457-2019·2019-02-20

    Promise Pharmacy Recalls Epithalon Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling Epithalon 15mg injections due to a lack of sterility assurance. The affected lots were distributed nationwide.

    Product
    Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0832-2019·2019-02-20

    AtriCure COBRA FUSION 150 Ablation System Recalled for Thromboembolism Risk

    AtriCure is recalling 765 units of the COBRA FUSION 150 Ablation System due to a potential elevated risk of thromboembolism during specific off-pump procedures.

    Product
    COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Drugs)·D-0465-2019·2019-02-20

    Promise Pharmacy Recalls Melanotan II Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 43 vials of Melanotan II injections because the product lacks sterility assurance. The affected lots were distributed nationwide.

    Product
    Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0462-2019·2019-02-20

    Promise Pharmacy Recalls HCG Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 819 vials of HCG injections nationwide due to a lack of sterility assurance.

    Product
    HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0451-2019·2019-02-20

    Promise Pharmacy Recalls Sermorelin Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 296 vials of Sermorelin/GHRP2/GHRP6 injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0445-2019·2019-02-20

    Promise Pharmacy Recalls Glutathione Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling specific lots of Glutathione Injection because of a lack of sterility assurance. The affected products were distributed nationwide.

    Product
    Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0455-2019·2019-02-20

    Promise Pharmacy Recalls Ipamorelin Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 93 vials of Ipamorelin injections nationwide due to a lack of sterility assurance.

    Product
    Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0435-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone Ophthalmic Solution Due to Sterility Concerns

    Promise Pharmacy is recalling compounded Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution due to a lack of sterility assurance.

    Product
    Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0442-2019·2019-02-20

    Promise Pharmacy Recalls Methylcobalamin Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 252 vials of Methylcobalamin Injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0479-2019·2019-02-20

    Promise Pharmacy Recalls Glycyrrhizic Acid Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling specific lots of Glycyrrhizic Acid Injection because of a lack of sterility assurance. The affected product was distributed nationwide.

    Product
    Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V114000·2019-02-20

    Audi Recalls 2019 Models for Front Shock Absorber Cracks

    Audi is recalling 2019 Q7, Q8, S5, and S5 Cabriolet vehicles because front shock absorber forks may crack, potentially impairing steering and increasing crash risk.

    Product
    AUDI — AUDI Q8, Q7, S5 CABRIOLET, S5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0438-2019·2019-02-20

    Promise Pharmacy Recalls Vitamin B Complex Vials Due to Sterility Concerns

    Promise Pharmacy is recalling 204 vials of compounded Vitamin B Complex due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL vial, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists, 31818 US Hwy 19N, Palm Harbor FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0441-2019·2019-02-20

    Promise Pharmacy Recalls Trim Complete Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 158 vials of Trim Complete injection nationwide due to a lack of sterility assurance.

    Product
    Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide Dexpanthenol/Pyridoxine/Methylcobalamin/Leucine/Chromium 25 mg/50 mg/50 mg/25 mg/2.5 mg/25 mg/2 mg/25 mg/0.5 mg2.5 mg/1.33 mcg/mL injection 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V113000·2019-02-20

    Porsche Recalls 718 Models for Potential Fuel Leak Fire Risk

    Porsche is recalling 2017-2019 718 Boxster and Cayman vehicles because a crossmember may detach in a crash, causing a fuel leak that increases fire risk.

    Product
    PORSCHE — PORSCHE 718 CAYMAN, 718 BOXSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0458-2019·2019-02-20

    Promise Pharmacy Recalls Bremelanotide Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 64 vials of Bremelanotide 20mg injections nationwide due to a lack of sterility assurance.

    Product
    Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0446-2019·2019-02-20

    Promise Pharmacy Recalls Ascorbic Acid Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 196 vials of Ascorbic Acid Injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0481-2019·2019-02-20

    Promise Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns

    Promise Pharmacy is recalling Folic Acid 5mg/ml injections because the product lacks sterility assurance. The recall covers nationwide distribution.

    Product
    Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0809-2019·2019-02-20

    Medtronic SENSIA Dual Chamber Pacemaker Recall for Circuit Error

    Medtronic is recalling SENSIA dual chamber pacemakers due to a potential circuit error that may affect device functionality when programmed to specific modes.

    Product
    Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·19E013000·2019-02-20

    MORryde Rubber Pin Box Recall for Improperly Torqued Bolts

    MORryde is recalling certain Rubber Pin Boxes because mounting bolts may have been improperly torqued, which could cause the trailer to detach from the tow vehicle.

    Product
    EQUIPMENT:MECHANICAL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0808-2019·2019-02-20

    Medtronic Pacemaker Recall: Circuit Error Affects Dual Chamber Functionality

    Medtronic is recalling 7,469 dual chamber pacemakers worldwide due to a circuit error that may affect device functionality when programmed to specific modes.

    Product
    Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0436-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone Ophthalmic Solution for Sterility Concerns

    Promise Pharmacy is recalling compounded Prednisolone and Gatifloxacin and Bromfenac ophthalmic solution due to lack of sterility assurance. The recall covers 900 bottles distributed nationwide.

    Product
    Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide