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.

16776–16800 of 29206

  • SevereFDA (Drugs)·D-0270-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Lipotropic Injections Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 987 vials of compounded Lipotropic injections nationwide because the agency could not ensure the products were sterile.

    Product
    Lipotropic (L-Carnitine 170 mg + Methylcobalamin 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 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0314-2017·2017-01-11

    Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling TriMix injections because the products may not be sterile. The recall covers vials compounded between May and November 2016.

    Product
    TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/0.5mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0290-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Sermorelin Forte Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling Sermorelin Forte 6 mg vials because the agency could not ensure the products were sterile.

    Product
    Sermorelin Forte 6 mg (Sermorelin Acetate 6 mg/GHRP-6 3 mg). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0838-2017·2017-01-11

    Country Fresh Diced Tri-Peppers Recalled for Listeria Monocytogenes Contamination

    Country Fresh Products is recalling diced tri-peppers sold under Bi-Lo, Harris Teeter, and Winn Dixie brands due to potential Listeria monocytogenes contamination.

    Product
    Diced Tri-Peppers, Net Wt. 6oz and 12oz, in clear plastic containers (sold under the Bi-Lo, Harris Teeter, and Winn Dixie brand).
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-0341-2017·2017-01-11

    FDA Recalls Compounded Injectable Due to Lack of Sterility Assurance

    Wells Pharmacy Network is recalling Arginine/Citrulline/Ornit+Lido injectable vials due to a lack of assurance of sterility.

    Product
    Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network, LLC, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0277-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Mineral Mix Schrader Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 36 vials of Mineral Mix Schrader because the agency cannot assure the products are sterile. The recall covers products compounded between May and November 2016.

    Product
    Mineral Mix Schrader, Zinc Chloride 5 mg/ml + Vanadium 100 mcg/ml + Manganese HCL 100 mcg/ml + Sodium Molybdate 250 mcg/ml + Strontium Chloride 3 mg/ml + Lithium Citrate 5 mg/ml + Chromium Picolinate 100 mcg/ml + Boron Citrate 1798 mg/ml + Sodium Selenite 200 mcg.ml + Cupric…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1159-2017·2017-01-11

    Royal Seafood Baza Recalls Herring Fillets Due to Listeria Risk

    Royal Seafood Baza, Inc. is recalling refrigerated herring fillets because they may be contaminated with Listeria monocytogenes.

    Product
    Refrigerated, Ready to Eat SUPER DUNAYSKAYA Herring Fillets in Oil sold under the FRESH SEAFOOD label, packaged in plastic retail containers (tubs), Net Weight 28.2 OZ./800 g.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0293-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Sermorelin Forte Plus Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 2,116 vials of Sermorelin Forte Plus 27 mg because the products lack assurance of sterility.

    Product
    Sermorelin Forte Plus 27 mg (Sermorelin Acetate 9 mg/GHRP-6 9 mg/GHRP-2 9 mg). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0323-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Ultra Cocktail #2 Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 123 vials of Ultra Cocktail #2 compounded between May and November 2016 because the agency cannot assure the products are sterile.

    Product
    Ultra Cocktail #2 (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 170mg/Thiamine HCL 20mg/Riboflavin-5-Phosphate Sod 2mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 20mg/Chromium Picolinate 66mcg/Lidocaine HCL 10mg/mL), (30 ML…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0365-2017·2017-01-11

    Wells Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Methylcobalamin 1,000 mcg/mL Injectable vials because the agency could not ensure the product was sterile.

    Product
    Methylcobalamin 1,000 mcg/mL Injectable, a) 10 mL vial and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0415-2017·2017-01-11

    Wells Pharmacy Recalls Trimix Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Trimix Injectable vials because the agency could not ensure the product was sterile. The recall covers vials prepared between February 2016 and September 2016.

    Product
    Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0327-2017·2017-01-11

    Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

    Wells Pharmacy is recalling Testosterone Cypionate in Grapeseed Oil Injectable vials because the product lacks assurance of sterility. The recall covers vials prepared between February 2016 and September 2016.

    Product
    Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0380-2017·2017-01-11

    Wells Pharmacy Recalls Mitomycin Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 2,336 Mitomycin 40 mg Injectable kits nationwide due to a lack of assurance of sterility.

    Product
    Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0396-2017·2017-01-11

    FDA Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (6) injectable kits nationwide due to a lack of assurance of sterility.

    Product
    Sermorelin Acetate/GHRP (6) 3 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0322-2017·2017-01-11

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

    Tri-Coast Pharmacy is recalling 870 vials of Ultra Amino Energy Cocktail nationwide due to a lack of assurance of sterility.

    Product
    Ultra Amino Energy Cocktail (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 125mg/Thiamine HCL 50mg/Riboflavin-5-Phosphate Sod 5mg/Miacinamide 20mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 50mg/Chromium Picolinate…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1158-2017·2017-01-11

    FDA Recalls Herring Fillets for Potential Listeria Contamination

    Royal Seafood Baza, Inc. is recalling refrigerated herring fillets due to potential Listeria monocytogenes contamination. Consumers should check their freezers for affected products.

    Product
    Refrigerated, Ready to Eat Herring Fillets in oil Lightly Salted sold under the FRESH SEAFOOD label, packaged in a plastic retail container (tub), Net Wt. 16 oz. (454g) - UPC 825512 014044 --- Produced by Royal Seafood Baza U.S.A.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0406-2017·2017-01-11

    Wells Pharmacy Recalls TitanMax Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 18 vials of TitanMax-MIC/12/CA/CH/L/D Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    TitanMax-MIC/12/CA/CH/L/D Injectable 25 mg/50 mg/50/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0336-2017·2017-01-11

    FDA Recalls Compounded HCG Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 10 kits of compounded Chorionic Gonadotropin (HCG) injectable kits due to a lack of assurance of sterility.

    Product
    Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0343-2017·2017-01-11

    Wells Pharmacy Recalls Bimix Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Bimix 30 mg/1 mg/mL Injectable vials because the product lacks assurance of sterility.

    Product
    Bimix 30 mg/1 mg/mL Injectable, a) 5 mL and b) 10 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0256-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Dexpanthenol Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling Dexpanthenol 250 mg/mL vials because the agency could not ensure the products were sterile.

    Product
    Dexpanthenol 250 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0384-2017·2017-01-11

    Wells Pharmacy Recalls QUAD2 Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling QUAD2 injectable vials because they may not be sterile. The recall covers vials prepared between February and September 2016.

    Product
    QUAD2 (PAP/PHEN/ALPROS/ATRO) 9 mg/1 mg/10 mg/0.1 mg/mL Injectable a) 2 mL and b) 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide