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.

16876–16900 of 29206

  • SevereFDA (Drugs)·D-0315-2017·2017-01-11

    Tri-Coast Pharmacy Recalls TriMix Injections Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 141 vials of TriMix compounded injections nationwide due to a lack of assurance of sterility.

    Product
    TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0383-2017·2017-01-11

    Wells Pharmacy Recalls QUAD1 Injectable Vials Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling QUAD1 injectable vials because the FDA determined there is a lack of assurance of sterility.

    Product
    QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0389-2017·2017-01-11

    FDA Recalls Sermorelin Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP Injectable Kits nationwide because the agency cannot assure the product is sterile.

    Product
    Sermorelin Acetate/GHRP (2) & (6) 9 mg/3.15 mg/3.15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1154-2017·2017-01-11

    FDA Recalls Fresh Seafood Herring Fillets for Listeria Risk

    Royal Seafood Baza, Inc. is recalling refrigerated herring fillets in oil due to potential Listeria monocytogenes contamination.

    Product
    Refrigerated, Ready to Eat Herring Fillet in Oil sold under the FRESH SEAFOOD label, packaged in plastic retail containers (tubs), Net Wt. 10.9 oz. (310g) - UPC 825512 004977, and Net Wt. 16.2 oz. (460g) - UPC 825512 004984 --- Manufactured by R.S.B., NY 10303
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0347-2017·2017-01-11

    Wells Pharmacy Recalls Chorionic Gonadotropin Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 1,753 kits of compounded Chorionic Gonadotropin injectable kits nationwide due to a lack of assurance of sterility.

    Product
    Chorionic Gonadotropin, Lyophilized, 3,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0338-2017·2017-01-11

    Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 21 vials of Testosterone Cypionate in Sesame Oil Injectable due to a lack of assurance of sterility.

    Product
    Testosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0375-2017·2017-01-11

    Wells Pharmacy Recalls MIC/Chromium/B12 Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 648 vials of MIC/Chromium/B12(M) Injectable because the agency cannot assure the product is sterile.

    Product
    MIC/Chromium/B12(M) Injectable, 25 mg/50 mg/50 mg/25 mcg/1 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0301-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 1,544 vials of compounded Testosterone Cypionate/Zinc Gluconate in Sesame Oil nationwide due to a lack of assurance of sterility.

    Product
    Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0279-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Pyridoxine HCL Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling compounded Pyridoxine HCL 100 mg/ml vials because there is a lack of assurance of sterility.

    Product
    Pyridoxine HCL 100 mg/ml, (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V026000·2017-01-11

    Subaru Recalls Vehicles Due to Passenger Air Bag Inflator Rupture Risk

    Subaru is recalling specific model years of Baja, Impreza, Forester, Legacy, Outback, and Tribeca vehicles to replace passenger air bag inflators that may rupture in a crash.

    Product
    SUBARU — SUBARU BAJA, IMPREZA, FORESTER, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0335-2017·2017-01-11

    Wells Pharmacy Recalls Ultra-Test Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 325 vials of Ultra-Test Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0852-2017·2017-01-11

    Country Fresh Celery and Onion Dice Recalled for Listeria Risk

    Country Fresh Products is recalling 6-ounce containers of Celery/Onion Dice sold under Bi-Lo and Winn Dixie brands due to potential Listeria monocytogenes contamination.

    Product
    Celery/Onion Dice, Net Wt. 6oz, in clear plastic containers (sold under the Bi-Lo and Winn Dixie brands)
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-0374-2017·2017-01-11

    Wells Pharmacy Recalls MIC/B-Complex Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 984 vials of MIC/B-Complex Injectable because the product lacks assurance of sterility.

    Product
    MIC/B-COMPLEX 15 mg/50 mg/100 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0317-2017·2017-01-11

    Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling TriMix compounded injections because the agency could not ensure the products were sterile.

    Product
    TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/10mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0273-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Methylcobalamin/Folic Acid/Pyridoxine Injections

    Tri-Coast Pharmacy is recalling 99 vials of compounded Methylcobalamin/Folic Acid/Pyridoxine injections due to a lack of assurance of sterility.

    Product
    Methylcobalamin/Folic Acid/Pyridoxine 1 mg/1 mg/50 mg/mL, 1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0348-2017·2017-01-11

    Wells Pharmacy Recalls Chorionic Gonadotropin Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 5,277 kits of compounded Chorionic Gonadotropin injectable kits nationwide due to a lack of assurance of sterility.

    Product
    Chorionic Gonadotropin, Lyophilized, 5,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0378-2017·2017-01-11

    Wells Pharmacy Recalls Mitomycin Solution Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 41 syringes of Mitomycin Solution Injectable because the agency could not ensure the product was sterile.

    Product
    Mitomycin Solution Injectable, Sterile 0.04%, 400 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0407-2017·2017-01-11

    FDA Recalls Tri 1 Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Tri 1 (PAP/PHEN/ATROPINE) NR Injectable vials because the product lacks assurance of sterility.

    Product
    Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0419-2017·2017-01-11

    Wells Pharmacy Recalls Tri-Test 200 Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 550 vials of Tri-Test 200 Injectable because there is a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Tri-Test 200 (CEP 100-75-25) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0385-2017·2017-01-11

    Wells Pharmacy Recalls QUAD4 Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling QUAD4 injectable vials because the FDA determined there is a lack of assurance of sterility.

    Product
    QUAD4 (PAP/PHEN/ALPROS/ATRO) 30 mg/3 mg/60 mcg/0.2 mg/mL Injectable, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0246-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Amino Energy Cocktail Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 59 vials of Amino Energy Cocktail because the agency cannot assure the sterility of the compounded product.

    Product
    Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25 mg/Methylcobalamin 300 mcg/Carnitine (L) 125 mg/Thiamine HCL 50 mg/Riboflavin-5-Phosphate Sod 5 mg/Niacinamide 20 mg/Pyridoxine HCL 2 mg/Folic Acid 2 mg/Ascorbic Acid 50 mg/Chromium…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0271-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Lipotropic with MIC Vials Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 236 vials of Lipotropic with MIC compounded between May and November 2016 due to a lack of assurance of sterility.

    Product
    Lipotropic with MIC (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25mg/L-Carnitine 170 mg + Methylcopalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-Phosphate Sod 2 mg + Niacinamide 20 mg + Pyridoxine HCL 2 mg + Folic Acid 1 mg/Lidocaine HCL 20mg/ml, (30 ML).…
    Category
    Drug
    Distribution
    Distributed nationwide