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.

16801–16825 of 29206

  • SevereFDA (Food)·F-1153-2017·2017-01-11

    Royal Seafood Baza Recalls Herring Fillets for Listeria Risk

    Royal Seafood Baza is recalling refrigerated herring fillets sold as 'Matjes' due to potential Listeria monocytogenes contamination.

    Product
    Refrigerated, Ready to Eat Herring in Brine, Herring Fillet "Matjes" sold under the FRESH SEAFOOD label, packaged in plastic retail containers (tubs), Net Wt. 10.9 oz. (310g) - UPC 825512 004953 and Net Wt. 16.2 oz. (460g) - UPC 825512 004960 -- Manufactured by R.S.B. NY 10303
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0358-2017·2017-01-11

    Wells Pharmacy Recalls Injectable Compounds Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 147 vials of a compounded injectable drug due to a lack of assurance of sterility. The products were distributed nationwide.

    Product
    Glutamine/ORNI/Arginine/LYS/CITRU+LIDO 75 mg/75 mg/150 mg/50 mg/100 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0392-2017·2017-01-11

    FDA Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (2) Injectable Kits nationwide due to a lack of assurance of sterility.

    Product
    Sermorelin Acetate/GHRP (2) Kit 6 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0298-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 400 vials of compounded Testosterone Cypionate in Sesame because the products lack assurance of sterility.

    Product
    Testosterone Cypionate in Sesame, 150 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0334-2017·2017-01-11

    Wells Pharmacy Recalls Ultra-Test Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 714 vials of Ultra-Test in Grapeseed Oil Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    ULTRA-TEST in Grapeseed Oil (CYP 90%/PROP 10%) Injectable, 200 mg/mL, 8 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0373-2017·2017-01-11

    Wells Pharmacy Recalls MIC/B-COMP+LIDO Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable vials due to a lack of assurance of sterility.

    Product
    MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0330-2017·2017-01-11

    Wells Pharmacy Recalls QUAD3 Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling QUAD3 injectable vials because the FDA determined there is a lack of assurance of sterility.

    Product
    QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0254-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Calcium Gluconate Injection Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 12 vials of Calcium Gluconate 10% Injection compounded between May and November 2016 due to a lack of assurance of sterility.

    Product
    Calcium Gluconate 10% Injection (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1137-2017·2017-01-11

    Chapel Hill Creamery Recalls Burrata Due to Salmonella Contamination Risk

    Chapel Hill Creamery LLC is recalling retail burrata sold in water due to potential Salmonella contamination. The product was distributed in five southeastern states.

    Product
    Burrata, is sold by each, retail only, packaged in water.
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0370-2017·2017-01-11

    Wells Pharmacy Recalls Injectable Compounds Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 933 vials of MIC/B-COMP/(M)/CHROM/CARN Injectable due to a lack of assurance of sterility.

    Product
    MIC/B-COMP/(M)/CHROM/CARN, 20 mg/40 mg/50 mg/25 mcg/25 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0391-2017·2017-01-11

    Wells Pharmacy Recalls Sermorelin Injectable Kits Due to Sterility Concerns

    Wells Pharmacy is recalling Sermorelin Acetate/GHRP (2) Injectable Kits because the agency could not ensure the product was sterile.

    Product
    Sermorelin Acetate/GHRP (2) 9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0328-2017·2017-01-11

    Wells Pharmacy Recalls Ultra-Test Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 157 vials of Ultra-Test Injectable nationwide due to a lack of assurance of sterility.

    Product
    ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 250 mg/mL 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0853-2017·2017-01-11

    Winn Dixie Mush & Garlic Herb Steak Recalled for Listeria Risk

    Country Fresh Products is recalling Winn Dixie Mush & Garlic Herb Steak due to potential Listeria monocytogenes contamination.

    Product
    Winn Dixie, Mush & Garlic Herb Steak 7.5oz
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-0379-2017·2017-01-11

    Wells Pharmacy Recalls Mitomycin Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Mitomycin 20 mg kits nationwide due to a lack of assurance of sterility.

    Product
    Mitomycin 20 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0331-2017·2017-01-11

    Wells Pharmacy Recalls Phenylephrine HCl Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 1,968 vials of Phenylephrine HCl Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Phenylephrine HCl Injectable, 1 mg/mL (0.1%), 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0420-2017·2017-01-11

    Wells Pharmacy Recalls Vitamin D3 Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 237 vials of Vitamin D3 in Sesame Oil Injectable due to a lack of assurance of sterility.

    Product
    Vitamin D3 in Sesame Oil Injectable 100,000 IU/mL, 5 mL, vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0371-2017·2017-01-11

    Wells Pharmacy Recalls Compounded Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 511 vials of a compounded injectable drug due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    MIC/BCOMP+CAR+ARG+CHR+LID 12.5 mg/25 mg/25 mg/25 mg/12.5 mg/0.2 mg/20 mg/mL Injectable, a) 10 mL and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1162-2017·2017-01-11

    Midwest International Longan Aril Recalled for Unsafe Food Additives

    Midwest International Corp is recalling Longan Aril (10.6oz) containing unsafe additives and undeclared saccharin. The product was distributed to five retail stores in Illinois, Massachusetts, and Texas.

    Product
    LONGAN ARIL, NET WT: 10.6oz (300g), contains blue labeling
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0324-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Ultra Slim Shot Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 874 vials of Ultra Slim Shot compounded between May and November 2016 because the products lack assurance of sterility.

    Product
    Ultra Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50 mg/Methylcobalamin 1mg/Carnitine (L) 170mg/Pyridoxine HCL 2mg/Lidocaine HCL 10mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0404-2017·2017-01-11

    Wells Pharmacy Recalls Testosterone Propionate Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 469 vials of compounded Testosterone Propionate Injectable because the agency could not ensure the product was sterile.

    Product
    Testosterone Propionate Injectable, 100 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0386-2017·2017-01-11

    FDA Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns

    Wells Pharmacy is recalling 568 Sermorelin Acetate 15 mg Injectable Kits nationwide due to a lack of assurance of sterility.

    Product
    Sermorelin Acetate 15 mg Injectable Kit., Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0309-2017·2017-01-11

    Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 17 vials of TriMix injection because the agency could not ensure the products were sterile.

    Product
    TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0408-2017·2017-01-11

    FDA Recalls Tri 2 Injectable Due to Lack of Sterility Assurance

    Wells Pharmacy Network LLC is recalling Tri 2 (PAP/PHEN/ATROPINE) NR Injectable vials because the product lacks assurance of sterility.

    Product
    Tri 2 (PAP/PHEN/ATROPINE) NR Injectable, 30 mg/3 mg/0.3 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0285-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Quad Mix Sterile Compounded Drug

    Tri-Coast Pharmacy is recalling Quad Mix sterile compounded drug vials due to a lack of assurance of sterility.

    Product
    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide