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.

16726–16750 of 29206

  • SevereNHTSA·17V032000·2017-01-11

    Audi Recalls Vehicles Due to Passenger Air Bag Inflator Rupture Risk

    Volkswagen Group of America is recalling specific Audi models because passenger air bag inflators may rupture during deployment, potentially causing serious injury or death.

    Product
    AUDI — AUDI A4, A6, S6, S4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0416-2017·2017-01-11

    Wells Pharmacy Recalls Trimix Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Trimix Injectable vials nationwide due to a lack of assurance of sterility.

    Product
    Trimix Injectable 30 mg/1 mg/25 mcg/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0361-2017·2017-01-11

    Wells Pharmacy Recalls Glutathione Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 148 vials of Glutathione 200 mg/mL Injectable nationwide due to a lack of assurance of sterility.

    Product
    Glutathione 200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0339-2017·2017-01-11

    Wells Pharmacy Recalls Alprostadil Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 37 vials of compounded Alprostadil 40 mcg/mL Injectable due to a lack of assurance of sterility.

    Product
    Alprostadil 40 mcg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0329-2017·2017-01-11

    Wells Pharmacy Recalls Testosterone Enanthate Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 1,250 vials of compounded Testosterone Enanthate Injectable nationwide due to a lack of assurance of sterility.

    Product
    Testosterone Enanthate in Grapeseed Oil Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0308-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Tri-Amino Sterile Compounded Products

    Tri-Coast Pharmacy is recalling 78 vials of Tri-Amino sterile compounded products due to a lack of assurance of sterility.

    Product
    Tri-Amino (Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg/Lidocaine HCL 10 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1152-2017·2017-01-11

    Royal Seafood Baza Recalls Pacific Herring Fillets for Listeria Risk

    Royal Seafood Baza, Inc. is recalling refrigerated Pacific Herring Fillets in Oil due to potential Listeria monocytogenes contamination. The product was distributed in seven states.

    Product
    Refrigerated, Ready to Eat Pacific Herring Fillet in Oil sold under the firm's FRESH SEAFOOD label in plastic retail containers (tubs), Net Wt. 10.9 oz. (310g) - UPC 825512 004939, and Net Wt. 16.2 oz. (460g) - UPC 825512 004946 --- Manufactured By: R.S.B. Staten Island, NY…
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0296-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Taurine Vials Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 90 vials of compounded Taurine 50 mg/mL because the products lack assurance of sterility.

    Product
    Taurine 50 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0353-2017·2017-01-11

    Wells Pharmacy Recalls Dexamethasone Sodium Phosphate Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 15 vials of Dexamethasone Sodium Phosphate 200 mg/mL injectable compounded in Ocala, FL, due to a lack of assurance of sterility.

    Product
    Dexamethasone Sodium Phosphate 200 mg/mL, Injectable, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0302-2017·2017-01-11

    FDA Recalls Tri-Coast Pharmacy Testosterone Cypionate Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 1,244 vials of compounded Testosterone Cypionate in Sesame Oil nationwide due to a lack of assurance of sterility.

    Product
    Testosterone Cypionate in Sesame Oil, 250 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0363-2017·2017-01-11

    FDA Recalls LipoLean Injectable Vials Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 433 vials of LipoLean injectable compounded in Florida due to a lack of assurance of sterility.

    Product
    Inositol/Choline/B-Complex+Leucine+CARN+CHROM+LIDO (LipoLean), Injectable, 30 mL vial, Compounded by Wells Pharmacy. Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0333-2017·2017-01-11

    Wells Pharmacy Recalls NADH Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling NADH injectable compounded in Ocala, FL, due to a lack of assurance of sterility.

    Product
    Nicotinamide Adenine Dinucleotide (NADH) - Lyophilized (P.F.) 100 mg Injectable, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0321-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Ultra Amino Blend Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 79 vials of Ultra Amino Blend because the FDA determined there is a lack of assurance of sterility for the compounded product.

    Product
    Ultra Amino Blend (Arginine HCL 105 mg + Lysine (L) HCL 150 mg + Ornithine (L) HCL 75 mg + Glutamine (L) 75 mg/ml + Lidocaine HCL 10 mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1134-2017·2017-01-11

    Chapel Hill Creamery Recalls Smoked Mozzarella for Salmonella Risk

    Chapel Hill Creamery is recalling smoked mozzarella products due to potential Salmonella contamination. The products were distributed in five southeastern states.

    Product
    Smoked Mozzarella, sold in 1 lb logs, half lb balls, Chapel Hill Creamery, Chapel Hill, NC 27516, and cherry-sized balls. At retail the half lb balls are sold by the each, packaged in water. All sizes are sold at wholesale, either packaged in water or dry packed. At retail…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0422-2017·2017-01-11

    Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Testosterone Cypionate in Grapeseed Oil Injectable vials because the product lacks assurance of sterility.

    Product
    Testosterone Cypionate in Grapeseed Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0405-2017·2017-01-11

    Wells Pharmacy Recalls Titan Up Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 433 vials of Titan Up Injectable because the product may lack assurance of sterility.

    Product
    Titan Up (INOS/CHOL/LEU/CAR/CHRO/LID) Injectable 25 mg/25 mg/1.5 mg/25 mg/0.025 mg/10 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0289-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Sermorelin Acetate Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 91 vials of Sermorelin Acetate 15 mg compounded between May and November 2016 because the agency cannot assure the products are sterile.

    Product
    Sermorelin Acetate 15 mg. Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0280-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Quad Mix Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling Quad Mix compounded drug products because they may not be sterile. The recall covers vials compounded between May and November 2016.

    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
  • SevereFDA (Drugs)·D-0281-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Quad Mix Compounded Drug Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling Quad Mix compounded drug vials because the agency could not ensure the products were sterile.

    Product
    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/9mg/0.1mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0344-2017·2017-01-11

    Wells Pharmacy Recalls Carnitine-L Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 44 vials of Carnitine-L 250 mg/mL Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Carnitine-L 250 mg/mL Injectable, 30 mL vials, Rx only, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0400-2017·2017-01-11

    Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

    Wells Pharmacy is recalling Testosterone Cypionate in Grapeseed Oil Injectable vials because the agency could not ensure the product was sterile.

    Product
    Testosterone Cypionate in Grapeseed Oil Injectable, 100 mg/mL, a) 1mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0274-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Myers Cocktail #4 Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 66 vials of Myers Cocktail #4 compounded between May and November 2016 due to a lack of assurance of sterility.

    Product
    Myers Cocktail #4 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg/10-mL), (10 ML). Compounded by Tri-Coast…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0847-2017·2017-01-11

    Country Fresh Stir Fry Vegetable Recall for Listeria Risk

    Country Fresh Products is recalling Harris Teeter Stir Fry Vegetables due to potential Listeria monocytogenes contamination.

    Product
    Harris Teeter, SW Stir Fry Vegetable7oz
    Category
    Food
    Distribution
    12 states