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.

1476–1500 of 1691

  • SevereFDA (Drugs)·D-956-2013·2013-09-18

    FDA Recalls Estradiol Valerate Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Estradiol Valerate with Lidocaine injection because FDA inspections raised concerns about sterility assurance.

    Product
    ESTRADIOL VALERATE W/ LIDOCAINE 1% 40 MG/ML OIL INJ SOLN, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-967-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Hydrogen Peroxide Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Hydrogen Peroxide 3% Injectable because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    HYDROGEN PEROXIDE 3% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1007-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Triple-Testosterone Injections Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Triple-Testosterone oil injection solutions because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    TRIPLE-TESTOSTERONE 250 MG/ML OIL INJ SOLN and TRIPLE-TESTOSTERONE 200 MG/ML OIL INJ SOLN, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-960-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Compounded Glutamine Injection Solution

    Beacon Hill Medical Pharmacy is recalling compounded glutamine injection solution due to FDA inspectional findings regarding sterility assurance and quality control.

    Product
    GLUTAMINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-976-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Magnesium Chloride Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling all presentations of Magnesium Chloride Hexahydrate 20% Injectable due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    MAGNESIUM CHLORIDE HEXAHYDRATE 20% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-968-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Hyaluronidase Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Hyaluronidase 150 U/ML and 200 U/ML Injectable due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    HYALURONIDASE 150 U/ML and 200 U/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1028-2013·2013-09-18

    Pharmacy Creations Recalls Lidocaine Injection Due to Sterility Concerns

    Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection vials because the company cannot guarantee the product is sterile.

    Product
    Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph, NJ.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1010-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Vitamin D Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Vitamin D 50,000 I.U./ML Injectable due to FDA inspectional findings regarding sterility assurance and quality control.

    Product
    VITAMIN D 50,000 I.U./ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1032-2013·2013-09-18

    Wellness Pharmacy Recalls Methyl B12 Vials Due to Sterility Concerns

    Wellness Pharmacy is recalling Methyl B12 1 mg/mL single-use vials because laboratory results indicated microbial contamination and the FDA questioned the reliability of the testing.

    Product
    Methyl B12 1 mg/mL P.F., Single-Use Vial, a) 1 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-970-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Hydroxyprogesterone Caproate Injection

    Beacon Hill Medical Pharmacy is recalling Hydroxyprogesterone Caproate 250 mg/mL oil injection due to sterility assurance concerns identified during an FDA inspection.

    Product
    HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1012-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Alprostadil Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Alprostadil 100 mcg/mL injection solution because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    ALPROSTADIL 100 MCG/ML INJ SOLN, all sizes, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-977-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Magnesium Sulfate Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling all presentations of Magnesium Sulfate 50% Injectable due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    MAGNESIUM SULFATE 50% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-964-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Glycine Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Glycine 50 mg/mL injectable products because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    GLYCINE 50 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-948-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Dexpantenol Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Dexpantenol 250 mg/mL injectable products because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.

    Product
    DEXPANTHENOL 250 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-952-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Dual-Testosterone Injections for Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Dual-Testosterone oil injection solutions due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    DUAL-TESTOSTERONE 20, 50, 100, 150, 200 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-955-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Estradiol Cypionate Injections for Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling compounded estradiol cypionate injections due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    ESTRADIOL CYPIONATE 5, 10, 40 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1000-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Sodium Phosphate Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Sodium Phosphate Dibasic/Water for Injection 10% because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-978-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Methylcobalamin Injections Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Methylcobalamin injections because FDA inspections found quality control issues that impacted sterility assurance.

    Product
    METHYLCOBALAMIN 1 mg/ml, 5 mg/ml, 10 mg/ml, 25 mg/ml and METHYLCOBALAMIN (PF) 1 MG/ML, 25 MG/ML INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-997-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Sermorelin Acetate Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Sermorelin Acetate 10 mg injectable because FDA inspectional findings raised concerns about sterility assurance and quality control.

    Product
    SERMORELIN ACETATE 10 MG INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1023-2013·2013-09-18

    University Compounding Pharmacy Recalls PGE-1 Injection Due to Sterility Concerns

    University Compounding Pharmacy is voluntarily recalling PGE-1, 20 mcg/mL Injection in Normal Saline due to lack of assurance of sterility.

    Product
    PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Pharmacy, 855-398-1800.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1022-2013·2013-09-18

    University Compounding Pharmacy Recalls Testosterone Injection Due to Sterility Concerns

    University Compounding Pharmacy is voluntarily recalling Testosterone Cypionate/Testosterone Propionate Injection due to lack of assurance of sterility.

    Product
    Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1024-2013·2013-09-18

    University Compounding Pharmacy Recalls PGE-1 Injection Due to Sterility Concerns

    University Compounding Pharmacy is voluntarily recalling PGE-1 injections due to lack of assurance of sterility. The recall affects nationwide distribution.

    Product
    PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding Pharmacy, 855-398-1800.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-928-2013·2013-09-11

    Teva Recalls CARBOplatin Injection Due to Sterility Assurance Failure

    Teva Pharmaceuticals is recalling CARBOplatin Injection because the required reduction of endotoxin was not met during annual revalidation of the vial washer.

    Product
    CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1988-2013·2013-08-28

    Aspen Surgical Recalls Wound Closures Due to Sterility Concerns

    Aspen Surgical Products is recalling reinforced wound closure strips because FDA sampling indicated the product may not be sterile, posing a risk of infection.

    Product
    Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-877-2013·2013-08-21

    Pallimed Solutions Recalls Testosterone Injection Due to Sterility Concerns

    Pallimed Solutions is recalling Testosterone Cypionate/Propionate Injection nationwide because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.

    Product
    Testosterone Cypionate/Propionate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide