The Recall Desk

Hazard

Lack Of Sterility recalls

1,423 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,423
Critical
3
Severe
1,055
Most recent
2026-10-14

Of the 1,423 lack of sterility recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,055 (74%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all lack of sterility recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1001–1025 of 1423

  • SevereFDA (Drugs)·D-0266-2017·2017-01-11

    Tri-Coast Pharmacy Recalls L-Arginine HCL Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 41 vials of compounded L-Arginine HCL 100 mg/mL because there is a lack of assurance of sterility. The products were distributed nationwide.

    Product
    L-Arginine HCL 100 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
    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 (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-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-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-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-0394-2017·2017-01-11

    Wells Pharmacy Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (2) Injectable Kits because the agency could not ensure the products were sterile.

    Product
    Sermorelin Acetate/GHRP (2) 3 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0291-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Sermorelin Forte Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 188 vials of Sermorelin Forte 12 mg because the agency could not ensure the sterile products were free from contamination.

    Product
    Sermorelin Forte 12 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0381-2017·2017-01-11

    Wells Pharmacy Recalls NADH Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling NADH/Carnitine/Taurine/B12(M) Injectable kits because the agency could not ensure the product was sterile.

    Product
    NADH/Carnitine/Taurine/B12(M) Injectable, 100 mg/150 mg/150 mg/10 mg, Lyophilized Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0255-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Calm Me Compounded Sterile Product Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling Calm Me compounded sterile products because there is a lack of assurance of sterility. The recall covers 10 vials distributed nationwide.

    Product
    Calm Me (Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 mg/Theanine (L) 50 mg/Tryptophan (L) 10 mg/Lidocaine HCL 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0275-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Myers Cocktail #5 Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling Myers Cocktail #5 vials nationwide because the agency could not ensure the products were sterile.

    Product
    Myers Cocktail #5 (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 + Folic Acid 1 mg + Vitamin E Succinate 10…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0260-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Glutathione Vials Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 367 vials of compounded Glutathione 200 mg/mL nationwide because the products lack assurance of sterility.

    Product
    Glutathione 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0346-2017·2017-01-11

    Wells Pharmacy Recalls Compounded Chorionic Gonadotropin Injectable Kits

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

    Product
    Chorionic Gonadotropin (New York State), 11,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    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-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-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-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-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
  • 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