The Recall Desk

Hazard

Lack Of Sterility recalls

1,417 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,417
Critical
3
Severe
1,048
Most recent
2026-07-29

Of the 1,417 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 1,048 (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 1417

  • 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-0263-2017·2017-01-11

    Tri-Coast Pharmacy Recalls HCG Vials Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 5,229 HCG 11,000 IU vials nationwide because the FDA cannot ensure the products are sterile.

    Product
    HCG 11,000 IU Vial. Compounded by Tri-Coast Pharmacy
    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-0267-2017·2017-01-11

    Tri-Coast Pharmacy Recalls L-Carnitine Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 14 vials of L-Carnitine 250 mg/mL because the products lack assurance of sterility. The recall covers sterile products compounded between May 17, 2016, and November 17, 2016.

    Product
    L-Carnitine 250 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
    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-0377-2017·2017-01-11

    Wells Pharmacy Recalls Mitomycin Solution Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 122 syringes of Mitomycin Solution Injectable because the agency could not ensure the product was sterile.

    Product
    Mitomycin Solution Injectable, Sterile 0.02%, 200 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, 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-0288-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Sermorelin Acetate Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling Sermorelin Acetate 9 mg vials because there is a lack of assurance of sterility. The recall covers products compounded between May and November 2016.

    Product
    Sermorelin Acetate 9 mg. Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0247-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Amino Acid Recover Eaze Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 105 vials of Amino Acid Recover Eaze because the agency cannot assure the products are sterile.

    Product
    Amino Acid Recover Eaze (50 ML), Phenylaline (L) 8 mg/ml + Tyrosine (L) 0.45 mg/ml + L-Taurine 0.7 mg/ml. Compounded by Tri-Coast Pharmacy.
    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-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-0366-2017·2017-01-11

    Wells Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 265 vials of compounded Methylcobalamin 5,000 mcg/mL Injectable because the product lacks assurance of sterility.

    Product
    Methylcobalamin 5,000 mcg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    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-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-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-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 (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-0410-2017·2017-01-11

    Wells Pharmacy Recalls Trimix with Atropine Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Trimix with Atropine Injectable vials because they may lack assurance of sterility. The recall covers products prepared between February 22, 2016, and September 14, 2016.

    Product
    Trimix with Atropine Injectable 30 mg/3 mg/300 mcg/0.2 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0313-2017·2017-01-11

    Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 25 vials of TriMix injection because the products lack assurance of sterility. The recall covers products compounded between May and November 2016.

    Product
    TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/2mg/30mg/mL, (1 ML). 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-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-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-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 IU
    Category
    Drug
    Distribution
    Distributed nationwide