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.

1026–1050 of 1417

  • 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-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-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-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-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 Tri-Co
    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-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-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). Compound
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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-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-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-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-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
  • 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
  • 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-0278-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Nandrolone Decanoate Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 701 vials of Nandrolone Decanoate 200 mg/ml because the agency could not ensure the products were sterile.

    Product
    Nandrolone Decanoate 200 mg/ml, (5 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0227-2017·2016-12-28

    Meta Pharmacy Recalls Compounded Eye Drops Due to Sterility Concerns

    Meta Pharmacy Services is recalling Phenylephrine and Tropicamide compounded eye drops due to a lack of sterility assurance. The affected product was distributed to one consignee in Las Vegas.

    Product
    Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0200-2017·2016-12-21

    Cantrell Drug Recalls Neostigmine Methylsulfate Syringes Due to Sterility Concerns

    Cantrell Drug Company is recalling specific lots of Neostigmine Methylsulfate injection syringes because the firm cannot ensure the products are sterile.

    Product
    Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single-Dose Syringe, For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-046-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0184-2017·2016-12-21

    Cantrell Drug Recalls Calcium Chloride Bags Due to Sterility Concerns

    Cantrell Drug Company is recalling 80 bags of Calcium Chloride 1 g/50 mL due to a lack of assurance of sterility.

    Product
    Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag, Rx Only, Hospital/Office Use Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-175-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0010-2017·2016-10-19

    Leiter's Compounding Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns

    Leiter's Compounding is recalling Atropine Sulfate 0.01% ophthalmic solution because the filters used to produce the products were recalled, raising concerns about sterility.

    Product
    Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39
    Category
    Drug
    Distribution
    Distributed nationwide