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.

27451–27475 of 32222

  • SevereFDA (Drugs)·D-1041-2013·2013-09-25

    Leiter's Pharmacy Recalls Lidocaine/Phenylephrine Vials Due to Sterility Concerns

    Leiter's Pharmacy is recalling 728 vials of Lidocaine/Phenylephrine PF 1%/1.5% injectible solution because sterility cannot be assured after failed test results were incorrectly reported as passing.

    Product
    Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2227-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR suture anchors because pinholes in primary pouches may breach the sterile barrier, posing a risk of infection.

    Product
    OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1047-2013·2013-09-25

    JCB Labs Recalls Epinephrine Syringes Due to Sterility Concerns

    JCB Labs LLC is recalling 1,243 epinephrine syringes because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.

    Product
    Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Free/Sulfite Free, 1-mL Single-Use Syringe, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1038-2013·2013-09-25

    Leiter's Pharmacy Recalls Dextrose 50% Injection Vials Due to Sterility Concerns

    Leiter's Pharmacy is recalling 56 vials of Dextrose 50% Injection Solution because sterility cannot be assured after testing errors were discovered.

    Product
    Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1044-2013·2013-09-25

    JCB Labs Recalls Sodium Thiosulfate Injection Due to Sterility Concerns

    JCB Labs LLC is recalling 1,056 vials of Sodium Thiosulfate 25% injection because laboratory results indicate microbial contamination and sterility cannot be assured.

    Product
    Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Injection, 50 mL Single Dose Vial, For Office Use Only, JCB Laboratories, Wichita, KS.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V465000·2013-09-25

    Setra Recalls 2011-2014 Motorcoaches Due to Electrical Overload Risk

    Setra is recalling 2011-2014 S417 TC and 2012-2014 S407 CC motorcoaches because an electrical overload in the light control unit may cause a short circuit or vehicle fire.

    Product
    SETRA — SETRA S417 TC, S407 CC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1048-2013·2013-09-25

    Medaus Recalls Testosterone Cyp 200 mg/mL Due to Sterility Concerns

    Medaus, Inc. is recalling Testosterone Cyp 200 mg/mL injections because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.

    Product
    Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1054-2013·2013-09-25

    Medaus Recalls Sodium Ascorbate Injection Due to Sterility Concerns

    Medaus, Inc. is recalling 15,500 mL of Sodium Ascorbate 500 mg/mL injection due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1052-2013·2013-09-25

    Medaus Recalls Pyridoxine HCL Due to Sterility Concerns

    Medaus, Inc. is recalling Pyridoxine HCL 100 mg/mL due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1055-2013·2013-09-25

    Medaus Recalls NA Ascorbate Injection Due to Sterility Concerns

    Medaus, Inc. is recalling NA Ascorbate 500 mg/mL injection due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1888-2013·2013-09-25

    G. Debbas Chocolatier Recalls Zim Zam Dark Chocolate Due to Allergen Mislabeling

    G. Debbas Chocolatier is recalling Zim Zam Dark Chocolate with Rice Crisps because the product was packed in a container declaring it is vegan, despite the facility processing milk.

    Product
    Professor Zim Zam's Extraordinary Sweets; Dark Chocolate with Rice Crisps; All Natural, 55% Cocoa; Net Wt. 0.35 oz (9.9g) Go Picnic: Distributed by Go Picnic Brands, Chicago, IL 60613; Made in USA
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1053-2013·2013-09-25

    Medaus Recalls Magnesium Chloride Injection Due to Sterility Concerns

    Medaus, Inc. is recalling Magnesium Chloride 200 mg/mL PF, 100 mL vials due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    Magnesium Chl 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1039-2013·2013-09-25

    Leiter's Pharmacy Recalls Hyaluronidase Vials Due to Sterility Concerns

    Leiter's Pharmacy is recalling 810 vials of Hyaluron (hyaluronidase) 150 units/mL due to bacterial contamination and unverified sterility.

    Product
    Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1043-2013·2013-09-25

    JCB Labs Recalls Acetylcysteine Solution Due to Sterility Concerns

    JCB Labs LLC is recalling 903 vials of Acetylcysteine 20% Solution because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.

    Product
    Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1049-2013·2013-09-25

    Medaus Recalls Lipo-Injection Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Lipo-Injection w/ Lidocaine because laboratory results indicate microbial contamination and sterility cannot be assured.

    Product
    Lipo-Injection w/ Lidocaine (PF), Ascorbic Acid 50 mg; B1-50 mg; B2-5-PO4-5 mg; B3-50 mg; B5-5 mg; B6-5 mg; Cyano B12-100 mcg; Methionine 12.5 mg; Inositol-25 mg; Choline-25 mg; Lidocaine 10 mg/mL, 30 mL, Medaus Pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1060-2013·2013-09-25

    Hydroxocobalamin Injection Recalled Due to Failed Sterility Testing

    Northern New England Compounding Pharmacy is recalling one lot of Hydroxocobalamin Injection because third-party testing failed to confirm sterility.

    Product
    Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States Compounding Pharmacy, Littleton, NH 03561
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1051-2013·2013-09-25

    Medaus Recalls L-Glutathione Injection Due to Sterility Concerns

    Medaus, Inc. is recalling L-Glutathione 200 mg/mL PF, 100 mL, due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V452000·2013-09-23

    GM Recalls 2013-2014 Chevrolet Cruze for Axle Shaft Fracture Risk

    General Motors is recalling 2013-2014 Chevrolet Cruze vehicles with manual transmissions because the right front half shaft may fracture, potentially causing loss of power or unexpected movement.

    Product
    CHEVROLET — CHEVROLET CRUZE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V450000·2013-09-23

    Audi Recalls 2013-2014 S6 and S7 Models for Fuel Line Leak Risk

    Volkswagen is recalling 2013-2014 Audi S6 and S7 vehicles because a fuel line may leak, posing a fire risk if exposed to an ignition source.

    Product
    AUDI — AUDI S6, S7
    Category
    Vehicle
    Distribution
    Distributed nationwide