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.

1451–1475 of 1691

  • SevereFDA (Drugs)·D-1044-2013·2013-09-25

    JCB Labs Recalls Sodium Thiosulfate Injection Due to Sterility Concerns

    JCB Labs LLC is recalling 1,056 vials of Sodium Thiosulfate 25% injection because laboratory results indicate microbial contamination and sterility cannot be assured.

    Product
    Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Injection, 50 mL Single Dose Vial, For Office Use Only, JCB Laboratories, Wichita, KS.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1038-2013·2013-09-25

    Leiter's Pharmacy Recalls Dextrose 50% Injection Vials Due to Sterility Concerns

    Leiter's Pharmacy is recalling 56 vials of Dextrose 50% Injection Solution because sterility cannot be assured after testing errors were discovered.

    Product
    Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1052-2013·2013-09-25

    Medaus Recalls Pyridoxine HCL Due to Sterility Concerns

    Medaus, Inc. is recalling Pyridoxine HCL 100 mg/mL due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-950-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls DMSO 50% Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling DMSO 50% Injectable due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    DMSO 50% INJ 50 ML VIAL 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-1018-2013·2013-09-18

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

    Beacon Hill Medical Pharmacy is recalling Manganese Sulfate 0.1 mg/mL Injectable due to FDA inspectional findings regarding sterility assurance.

    Product
    MANGANESE SULFATE 0.1 MG/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-1033-2013·2013-09-18

    Wellness Pharmacy Recalls Phenylbutyrate Due to Sterility Concerns

    Wellness Pharmacy is recalling Phenylbutyrate 200 mg/mL vials because laboratory results indicate microbial contamination and the FDA has concerns about the reliability of the testing data.

    Product
    NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS PHARMACY, 1-800-227-2627
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1003-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Testosterone Cypionate Injections for Sterility Concerns

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

    Product
    TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/ML, 20 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-937-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Alprostadil Injection Due to Sterility Concerns

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

    Product
    ALPROSTADIL, 50 MCG/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-982-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Multitrace-5 Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Multitrace-5 Injectable because FDA inspectional findings raised concerns about quality control procedures impacting sterility assurance.

    Product
    MULTITRACE-5 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-1004-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Testosterone Propionate Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Testosterone Propionate 100 mg/mL oil injection solution because FDA inspections raised concerns about sterility assurance and quality control.

    Product
    TESTOSTERONE PROPIONATE 100 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-1034-2013·2013-09-18

    Wellness Pharmacy Recalls RL Glutathione Due to Sterility Concerns

    Wellness Pharmacy is recalling RL Glutathione 100 mg/mL vials due to laboratory results indicating microbial contamination and concerns about the reliability of testing.

    Product
    RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELLNESS PHARMACY, 1-800-227-2627
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-933-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Acetylcysteine Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Acetylcysteine 100 mg/mL injection solution because FDA inspectional findings raised concerns about quality control and sterility assurance.

    Product
    ACETYLCYSTEINE 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-993-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls PUMICE/LIDOCAINE HCL Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling PUMICE/LIDOCAINE HCL 1.5%/1% Injection Suspensions because FDA inspections raised concerns about sterility assurance.

    Product
    PUMICE/LIDOCAINE HCL 1.5%/1% INJ SUSP, 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-941-2013·2013-09-18

    FDA Recalls Bi-Mix Phentolamine/Papaverine Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Bi-Mix Phentolamine/Papaverine injectable products because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    BI-MIX PHENTOLAMINE/PAPAVERINE 0.5 MG/30 MG/ML and BI-MIX PHENTOLAMINE/PAPAVERINE 1 MG/30 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-946-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Cyanocobalamin Injections Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling compounded cyanocobalamin injections because FDA inspections raised concerns about sterility assurance and quality control.

    Product
    CYANOCOBALAMIN 1000 MCG/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-1031-2013·2013-09-18

    Wellness Pharmacy Recalls Magnesium Sulfate Vials Due to Sterility Concerns

    Wellness Pharmacy is recalling 590 vials of Magnesium Sulfate Hepta 50% PF due to laboratory results indicating microbial contamination and concerns about the reliability of testing.

    Product
    Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-943-2013·2013-09-18

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

    Beacon Hill Medical Pharmacy is recalling Calcium Chloride 100 mg/mL Injectable because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.

    Product
    CALCIUM CHLORIDE 100 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-1016-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Calcium EDTA Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Calcium EDTA 200 mg/mL injectable products because FDA inspectional findings raised concerns about quality control and sterility assurance.

    Product
    CALCIUM EDTA 200 MG/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-987-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Parabens Water for Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling all presentations of Parabens Water for Injection because FDA inspectional findings raised concerns about quality control procedures impacting sterility assurance.

    Product
    PARABEN WATER FOR INJECTION, 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-954-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Estradiol Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Estradiol Cypionate/Progesterone/Testosterone Cypionate injections due to FDA inspectional findings regarding sterility assurance.

    Product
    ESTRADIOL CYP/PROG/TEST CYP 0.5/10/10 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-1035-2013·2013-09-18

    Wellness Pharmacy Recalls Dexpanthenol Vials Due to Sterility Concerns

    Wellness Pharmacy is recalling 1,355 vials of Dexpanthenol 250 mg/mL due to laboratory results indicating microbial contamination and concerns about the reliability of testing.

    Product
    Dexpanthenol 250 mg/mL PF, Single Use Vial, 1 mL, WELLNESS PHARMACY, 1-800-227-2627
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-962-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Compounded Sterile Injection Due to Sterility Concerns

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

    Product
    GLUTATHIONE/LIDO 100MG/2%/ML (PF) 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-961-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Glutathione Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Glutathione 200 mg/mL injection solution because FDA inspections raised concerns about sterility assurance and quality control.

    Product
    GLUTATHIONE 200 MG/ML (PF) 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-1006-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Triamcinolone Acetonide Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling compounded Triamcinolone Acetonide injections because FDA inspections raised concerns about sterility assurance.

    Product
    TRIAMCINOLONE ACETONIDE 80 MG/ML INJ SUSP, 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-935-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls B-12/Lidocaine Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling B-12/Lidocaine 25/10mg/mL injections because FDA inspections raised concerns about sterility assurance and quality control.

    Product
    B-12/LIDOCAINE 25/10MG/ML, 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