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.

1026–1050 of 1423

  • SevereFDA (Drugs)·D-0254-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Calcium Gluconate Injection Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 12 vials of Calcium Gluconate 10% Injection compounded between May and November 2016 due to a lack of assurance of sterility.

    Product
    Calcium Gluconate 10% Injection (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0391-2017·2017-01-11

    Wells Pharmacy Recalls Sermorelin Injectable Kits Due to Sterility Concerns

    Wells Pharmacy is recalling Sermorelin Acetate/GHRP (2) Injectable Kits because the agency could not ensure the product was sterile.

    Product
    Sermorelin Acetate/GHRP (2) 9 mg/9 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-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-0404-2017·2017-01-11

    Wells Pharmacy Recalls Testosterone Propionate Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 469 vials of compounded Testosterone Propionate Injectable because the agency could not ensure the product was sterile.

    Product
    Testosterone Propionate Injectable, 100 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0408-2017·2017-01-11

    FDA Recalls Tri 2 Injectable Due to Lack of Sterility Assurance

    Wells Pharmacy Network LLC is recalling Tri 2 (PAP/PHEN/ATROPINE) NR Injectable vials because the product lacks assurance of sterility.

    Product
    Tri 2 (PAP/PHEN/ATROPINE) NR Injectable, 30 mg/3 mg/0.3 mg/mL, a) 2 mL and b) 5 mL vials, 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-0283-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Quad Mix Injection Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling Quad Mix injection vials because the FDA cannot assure the products are sterile. The recall covers vials compounded between May and November 2016.

    Product
    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/19mg/190mg/ml, (1 ML). 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-0258-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Glucosamine Vials Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 30 vials of compounded Glucosamine 200 mg/mL because the agency cannot assure the products are sterile.

    Product
    Glucosamine 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
    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-0310-2017·2017-01-11

    Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns

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

    Product
    TriMix, Alprostadil/Phentolamine/Papaverine 10mcg/0.5mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
    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-0292-2017·2017-01-11

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

    Tri-Coast Pharmacy is recalling 441 vials of Sermorelin Forte Plus 18 mg because the products lack assurance of sterility. The recall covers sterile products compounded between May 17, 2016, and November 17, 2016.

    Product
    Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 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-0316-2017·2017-01-11

    Tri-Coast Pharmacy Recalls TriMix Injections Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 13 vials of TriMix compounded injections because the agency could not ensure the products were sterile.

    Product
    TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/0.5mg/10mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0265-2017·2017-01-11

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

    Tri-Coast Pharmacy is recalling 132 vials of IV Cocktail #2 nationwide due to a lack of assurance of sterility.

    Product
    IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL), (30 ML). Compounded by…
    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-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-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-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 (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
  • HighFDA (Drugs)·D-0332-2017·2017-01-11

    Wells Pharmacy Recalls MIC Combo Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling MIC Combo injectable vials because the agency could not ensure the product was sterile.

    Product
    MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable, 30 mL vials, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0372-2017·2017-01-11

    Wells Pharmacy Recalls Injectable Compound Due to Sterility Assurance Concerns

    Wells Pharmacy Network LLC is recalling 1,716 vials of a compounded injectable product nationwide due to a lack of assurance of sterility.

    Product
    MIC/B-COMP+CARN+LIDO, 15 mg/30 mg/30 mg/85 mg/20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide