The Recall Desk

Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,691
Critical
12
Severe
931
Most recent
2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility failure 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 1691

  • HighFDA (Drugs)·D-0529-2017·2017-03-22

    Synergy Rx Recalls Bicarbonate 10% Due to Sterility Assurance Concerns

    Synergy Rx is recalling Bicarbonate 10% because the product lacks assurance of sterility and has CGMP deviations.

    Product
    BICARBONATE 10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0543-2017·2017-03-22

    Synergy Rx Recalls Salicylic Acid and 5-FU Products for Sterility Concerns

    Synergy Rx is recalling salicylic acid and 5-FU prescription products due to lack of assurance of sterility and CGMP deviations.

    Product
    SALICYLIC ACID SOLUTION in all strengths including 20%, 25%, 30%, and 40%, SALICYCLIC ACID 20%. 2.5%5-FU, SALICYCLIC ACID 20%, 5-FU 2.5% CREAM, SALICYCLIC ACID 20%/5-FU 2.5% MEDICATION STICK, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0590-2017·2017-03-22

    Synergy Rx Recalls Melatonin Spray Due to Sterility Assurance Concerns

    Synergy Rx is recalling Melatonin 1.5mg Spray because the product lacks assurance of sterility and has CGMP deviations.

    Product
    MELATONIN 1.5MG SPRAY, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0544-2017·2017-03-22

    Synergy Rx Recalls Trichloroacetic Acid Solutions Due to Sterility Concerns

    Synergy Rx is recalling Trichloroacetic Acid Solutions in various strengths due to a lack of assurance of sterility and CGMP deviations.

    Product
    TRICHLOROACETIC ACID SOLUTION in all strengths including: 10%, 12%, 15 %, 20%, 35%, 70%, and 85%, TRICHLOROCETIC ACID 10%/ LACTIC ACID 12%, TRICHLOROCETIC ACID 6%/LACTIC ACID 12%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2017·2017-03-01

    Custom Medical Specialties Recalls Biopsy Trays with Syringes Due to Sterility Concerns

    Custom Medical Specialties is recalling 80 biopsy trays containing syringes because the sterility of the syringes could not be assured. The affected products were distributed to Idaho and Oregon.

    Product
    CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0270-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Lipotropic Injections Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 987 vials of compounded Lipotropic injections nationwide because the agency could not ensure the products were sterile.

    Product
    Lipotropic (L-Carnitine 170 mg + Methylcobalamin 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 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0246-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Amino Energy Cocktail Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 59 vials of Amino Energy Cocktail because the agency cannot assure the sterility of the compounded product.

    Product
    Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25 mg/Methylcobalamin 300 mcg/Carnitine (L) 125 mg/Thiamine HCL 50 mg/Riboflavin-5-Phosphate Sod 5 mg/Niacinamide 20 mg/Pyridoxine HCL 2 mg/Folic Acid 2 mg/Ascorbic Acid 50 mg/Chromium Picolin
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0290-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Sermorelin Forte Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling Sermorelin Forte 6 mg vials because the agency could not ensure the products were sterile.

    Product
    Sermorelin Forte 6 mg (Sermorelin Acetate 6 mg/GHRP-6 3 mg). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0261-2017·2017-01-11

    Tri-Coast Pharmacy Recalls HCG Vials Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 4,884 vials of HCG 5,000 IU due to a lack of assurance of sterility. The products were distributed nationwide.

    Product
    HCG 5,000 IU Vial. Compounded by Tri-Coast Pharmacy.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0287-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Sermorelin Acetate Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 260 vials of Sermorelin Acetate 6 mg compounded between May and November 2016 because the agency cannot assure the products are sterile.

    Product
    Sermorelin Acetate 6 mg. Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0286-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Quad Mix Compounded Sterile Drug Vials

    Tri-Coast Pharmacy is recalling 17 vials of Quad Mix compounded sterile drug due to a lack of assurance of sterility. The products were distributed nationwide.

    Product
    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 18mcg/1mg/1.8mg/0.02mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0282-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Quad Mix Due to Sterility Concerns

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

    Product
    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/3mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0373-2017·2017-01-11

    Wells Pharmacy Recalls MIC/B-COMP+LIDO Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable vials due to a lack of assurance of sterility.

    Product
    MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0306-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Testosterone Suspension Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 13 vials of compounded Testosterone Suspension 100 mg/mL due to a lack of assurance of sterility. The recall covers products compounded between May and November 2016.

    Product
    Testosterone Suspension 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    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 (Drugs)·D-0421-2017·2017-01-11

    Wells Pharmacy Recalls Vitamin D3 Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 335 vials of Vitamin D3 in Sesame Oil Injectable due to a lack of assurance of sterility.

    Product
    Vitamin D3 in Sesame Oil Injectable 50,000 IU/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0322-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Ultra Amino Energy Cocktail Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 870 vials of Ultra Amino Energy Cocktail nationwide due to a lack of assurance of sterility.

    Product
    Ultra Amino Energy Cocktail (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 125mg/Thiamine HCL 50mg/Riboflavin-5-Phosphate Sod 5mg/Miacinamide 20mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 50mg/Chromium Picolinate 200mcg/Glu
    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-0406-2017·2017-01-11

    Wells Pharmacy Recalls TitanMax Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 18 vials of TitanMax-MIC/12/CA/CH/L/D Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    TitanMax-MIC/12/CA/CH/L/D Injectable 25 mg/50 mg/50/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0276-2017·2017-01-11

    Tri-Coast Pharmacy Recalls MIC Ultra Cocktail Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 278 vials of MIC Ultra Cocktail nationwide due to a lack of assurance of sterility.

    Product
    MIC Ultra Cocktail (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 700mcg/Chromium Picolinate 20 mcg/Pyridoxine HCL 2mg/ml), (10 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0285-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Quad Mix Sterile Compounded Drug

    Tri-Coast Pharmacy is recalling Quad Mix sterile compounded drug vials due to a lack of assurance of sterility.

    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-0345-2017·2017-01-11

    Wells Pharmacy Recalls Ceftazidime Ophthalmic Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 46 kits of compounded Ceftazidime Ophthalmic 2.25% due to a lack of assurance of sterility.

    Product
    Ceftazidime, Lyophilized, Ophthalmic 2.25% Kit, Rx only, Compounded by Wells Pharmacy, Ocala , FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0269-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Lipo-C Vials Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 69 vials of Lipo-C compounded between May and November 2016 because the agency could not ensure the products were sterile.

    Product
    Lipo-C (Methionine 25 mg/Inositol 50 mg/Choline Chloride 50 mg/Carnitine (L) 100 mg/Methylcobalamin 1 mg/Thiamine HCL 50 mg/Rivoflavin-5-Phosphate Sod 5 mg/Niacinamide 50 mg/Dexpanthenol 5 mg/Pyridoxine HCL 1.25 mg/Lidocaine HCL 10 mg/mL), (30 ML). Compounded by Tri-Coast Pharmac
    Category
    Drug
    Distribution
    Distributed nationwide