The Recall Desk

Hazard

Sterility recalls

2,383 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,383
Critical
1
Severe
2,113
Most recent
2026-08-26

Of the 2,383 sterility recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,113 (89%) 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 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.

101–125 of 2383

  • SevereFDA (Drugs)·D-0138-2021·2020-12-23

    Advanced Nutriceuticals Recalls DSIP Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling DSIP vials because production processes cannot assure sterility. The product was distributed to specific states.

    Product
    DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0165-2021·2020-12-23

    Cipla Recalls Azacitidine Injection Vials Due to Sterility Concerns

    Cipla is recalling 2,151 vials of Azacitidine for Injection due to potential sterility issues caused by improper sealing.

    Product
    Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0144-2021·2020-12-23

    Advanced Nutriceuticals Recalls Pentosan Polysulfate Vials Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling Pentosan Polysulfate vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0140-2021·2020-12-23

    FDA Recalls Thymosin Beta-4 Vials Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling Thymosin Beta-4 vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0128-2021·2020-12-23

    FDA Recalls CJC-1295 Vials Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling CJC-1295 vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0139-2021·2020-12-23

    FDA Recalls Cerebrolysin Vials Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling Cerebrolysin vials because production processes cannot assure sterility. The product was distributed to seven states.

    Product
    CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0131-2021·2020-12-23

    FDA Recalls AOD-9604 Vials Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling AOD-9604 vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0137-2021·2020-12-23

    Advanced Nutriceuticals Recalls B12 Injection Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling B12 for Injection vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2489-2020·2020-07-15

    Prodimed Combicath Catheters Recalled for Sterility Assurance Concerns

    Prodimed Plastimed Division is recalling 300 Combicath catheters nationwide due to a lack of assurance of sterility.

    Product
    Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm Product Code: 58229 19US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2491-2020·2020-07-15

    Prodimed Combicath Paediatric Catheters Recalled Due to Sterility Assurance Issues

    Prodimed Plastimed Division is recalling 180 units of Combicath Paediatric catheters nationwide because the company cannot assure the sterility of the devices.

    Product
    Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2492-2020·2020-07-15

    Prodimed Combicath Paediatric Catheters Recalled for Sterility Assurance Issues

    Prodimed is recalling Combicath Paediatric catheters due to a lack of assurance of sterility. The recall covers 2,580 units distributed nationwide.

    Product
    Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2488-2020·2020-07-15

    Prodimed Combicath Catheters Recalled Due to Sterility Assurance Concerns

    Prodimed Plastimed Division is recalling Combicath catheters for mini bronchoalveolar lavage because of a lack of assurance of sterility.

    Product
    Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1329-2020·2020-07-01

    BIOTA Biosciences Recalls Sterile Cannabidiol and Curcumin Vials

    BIOTA Biosciences is recalling sterile Cannabidiol and Curcumin vials due to lack of sterility assurance and lack of FDA approval.

    Product
    Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1096-2020·2020-04-15

    Innovative Compounding Pharmacy Recalls MIC-8 Injectable Due to Sterility Concerns

    Innovative Compounding Pharmacy is recalling MIC-8 injectable vials because the firm cannot assure the product's sterility. Patients in California, Maine, and Texas should stop using the product.

    Product
    MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1097-2020·2020-04-15

    Innovative Compounding Pharmacy Recalls Hydroxyprogesterone Caproate Due to Sterility Concerns

    Innovative Compounding Pharmacy is recalling Hydroxyprogesterone Caproate injections because the FDA cannot ensure the product is sterile. Patients in California, Maine, and Texas should stop using the medication.

    Product
    Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1098-2020·2020-04-15

    Innovative Compounding Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

    Innovative Compounding Pharmacy is recalling Testosterone Cypionate In Sesame Oil 200mg/ml injectable vials because the firm cannot assure the sterility of the product.

    Product
    Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1081-2020·2020-04-15

    PharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Concerns

    PharMEDium Services is recalling 46 lots of ePHEDrine Sulfate syringes because the company could not ensure the products were sterile.

    Product
    ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1665-2020·2020-04-15

    Biomet Knee Spacer Mold Recalled for Potential Cleaning Deficiencies

    Biomet is recalling StageOne Knee Femoral Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1649-2020·2020-04-15

    Biomet Hip Stem Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Drugs)·D-1074-2020·2020-04-08

    Medical Center Pharmacy Recalls Vancomycin Opthal Drops Due to Sterility Concerns

    Medical Center Pharmacy is recalling Vancomycin Opthal 14 mg drops because production processes could not assure sterility. The product was distributed to patients in Tennessee.

    Product
    C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1072-2020·2020-04-08

    Gentamicin Irrigation Recalled for Lack of Sterility Assurance

    The Medicine Shoppe Pharmacy is recalling Gentamicin 80mg/60 mL Irrigation containers due to a lack of assurance of sterility.

    Product
    Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1077-2020·2020-04-08

    Medical Center Pharmacy Recalls Mitomycin Eye Drops Due to Sterility Concerns

    Medical Center Pharmacy is recalling two bottles of Mitomycin 0.04% Ophth DR eye drops because production processes could not assure sterility.

    Product
    *Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05.
    Category
    Drug
    Distribution
    1 state