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.

851–875 of 2383

  • SevereFDA (Drugs)·D-0711-2017·2017-05-24

    Key Pharmacy Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Atropine Sulfate 0.01% Ophthalmic Solution because the firm cannot assure the sterility of the product.

    Product
    ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0742-2017·2017-05-24

    Key Pharmacy Recalls TRI MIX Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 25 vials of TRI MIX 20/20/1 injection due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.

    Product
    TRI MIX 20/20/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/20mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0769-2017·2017-05-24

    Key Pharmacy Recalls Methyl-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 26 vials of Methyl-B12 injection due to a lack of assurance of sterility.

    Product
    METHYL-B12 5ML MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0768-2017·2017-05-24

    Key Pharmacy Recalls Magnesium Sulfate Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Magnesium Sulfate 50% injections because the firm cannot assure the sterility of the product.

    Product
    MAGNESIUM SO4 10ML MDV 50% INJ, Injection, 50%, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0727-2017·2017-05-24

    Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling Hydroxo-B12 injections because the firm cannot guarantee the products are sterile.

    Product
    HYDROXO-B12 PBF MDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, packaged in a 5 mL and 30 mL Glass/ Multiple Dose vials, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0770-2017·2017-05-24

    Key Pharmacy Recalls Methyl-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 25 vials of Methyl-B12 injection due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.

    Product
    METHYL-B12 *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0718-2017·2017-05-24

    Key Pharmacy Recalls Folinic Acid Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Folinic Acid injections because the firm cannot guarantee the products are sterile.

    Product
    FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0729-2017·2017-05-24

    Key Pharmacy Recalls Papaverine/Phentolamine Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Papaverine/Phentolamine injections because the firm cannot assure the sterility of the product.

    Product
    PAPAVERINE/PHENT 5ML MDV 30/0.5MG/ML INJ, Injection, 30/0.5mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0726-2017·2017-05-24

    Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot guarantee the products are sterile.

    Product
    HYDROXO-B12 30ML PBF MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 30 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0778-2017·2017-05-24

    Key Pharmacy Recalls Sodium Bicarbonate Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Sodium Bicarbonate Injection because the firm cannot guarantee the product is sterile.

    Product
    SODIUM BICARB 50ML MDV 8.4% (2 MOSMOL/ML) INJ, Injection, 8.40%, Rx only, 5mL Glass/Multiple Dose via, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0786-2017·2017-05-24

    Key Pharmacy Recalls Vitamin D3 Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Vitamin D3 in Olive Oil Injection due to a lack of assurance of sterility.

    Product
    VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 150,000u/mL, Rx only, packaged in 2mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0783-2017·2017-05-24

    Key Pharmacy Recalls Testosterone Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Testosterone Injection due to a lack of assurance of sterility.

    Product
    TESTOST AQ MDV 50MG/ML INJ, Injection, 50mg/mL, Rx only, packaged in 5mL and 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0720-2017·2017-05-24

    Key Pharmacy Recalls HCG Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 72 vials of HCG injections because the firm cannot assure the sterility of the compounded drugs.

    Product
    HCG *10ML* MDV 500U/ML INJ, Injection, 500u/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0775-2017·2017-05-24

    FDA Recalls Compounded Progesterone Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling compounded progesterone injections because the firm cannot ensure the products are sterile.

    Product
    PROGESTERONE SESAME OIL 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass; Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0725-2017·2017-05-24

    Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot assure the sterility of the compounded drugs.

    Product
    HYDROXO-B12 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 5 mL Glass/ Multiple Dose and 30 mL Glass/ Multiple Dose vials,Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0737-2017·2017-05-24

    Key Pharmacy Recalls TRI MIX Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 200 vials of TRI MIX 10/30/0.5 injection due to a lack of assurance of sterility.

    Product
    TRI MIX 10/30/0.5 *5ML* MDV MCG/MG/MG/ML INJ, Injection,10mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0761-2017·2017-05-24

    Key Pharmacy Recalls Cyanocobalamin Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Cyanocobalamin injections because the firm cannot ensure the products are sterile.

    Product
    CYANOCOBALAMIN 10ML MDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0746-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.

    Product
    TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 30mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0730-2017·2017-05-24

    Key Pharmacy Recalls Papaverine/Phentolamine Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Papaverine/Phentolamine injection because the firm cannot assure the sterility of the product.

    Product
    PAPAVERINE/PHENT 5ML MDV 30/1MG/ML INJ, Injection, 30mg/1mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0782-2017·2017-05-24

    Key Pharmacy Recalls Testosterone Cypionate Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Testosterone Cypionate injections because the firm cannot guarantee the products are sterile.

    Product
    TESTOST CYP SESAME OIL 5ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0756-2017·2017-05-24

    Key Pharmacy Recalls PGE1/Procaine Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of PGE1/Procaine injections because the firm cannot guarantee the products are sterile.

    Product
    PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0709-2017·2017-05-24

    Key Pharmacy Recalls 5-MTHF Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 5-MTHF 10mL single-dose vials because the firm cannot assure the sterility of the product.

    Product
    5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0744-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX 20/30/1 injection due to a lack of assurance of sterility.

    Product
    TRI MIX 20/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0749-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 45.45/27.27/0.45 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.

    Product
    TRI MIX 45.45/27.27/0.45 5ML MDV MCG/MG/MG/ML INJ, Injection, 45.45mcg/27.27mg/0.45mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide