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.

1426–1450 of 1691

  • SevereFDA (Drugs)·D-322-2014·2013-12-11

    Main Street Compounding Pharmacy Recalls Wydase 5ml Due to Sterility Concerns

    Main Street Family Pharmacy is recalling 50 units of Wydase 5ml because the product lacks assurance of sterility. The recall covers units distributed nationwide prior to and including May 23, 2013.

    Product
    Wydase 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0123-2014·2013-11-06

    Globus Medical Recalls MicroFuse Putty Due to Sterility Assurance Concerns

    Globus Medical is recalling MicroFuse Putty because the sterility assurance level cannot be verified. The product is a bone graft extender used in medical procedures.

    Product
    Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filleris a bone graft extender to be used with autogenous bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66241-001·2013-10-09

    Apothecary Shoppe Recalls Estradiol and Progesterone Injectable Due to Sterility Concerns

    The Apothecary Shoppe is recalling Estradiol and Progesterone injectable vials due to concerns about sterility assurance with its testing laboratory.

    Product
    Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1068-2013·2013-10-09

    Triangle Compounding Recalls Sodium Phosphate Injectable Due to Sterility Concerns

    Triangle Compounding is recalling 54 vials of Sodium Phosphate Injectable because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.

    Product
    Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL Single Dose Vial, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1069-2013·2013-10-09

    Triangle Compounding Recalls Histamine Injectable Due to Sterility Concerns

    Triangle Compounding Pharmacy is recalling 8 vials of Histamine, 10 ng/mL Injectable due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-66241-002·2013-10-09

    Apothecary Shoppe Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

    The Apothecary Shoppe is recalling 1,430 mL of Testosterone Cypionate 200 mg/mL Injectable in Oklahoma due to concerns about sterility assurance.

    Product
    SIH-Testosterone Cypionate 200 mg/mL Injectable, 10 mL sterile vial, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1063-2013·2013-10-02

    Walgreens Recalls Progesterone Injection Lot Due to Sterility Concerns

    Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate injection due to sterility assurance concerns with its testing laboratory.

    Product
    Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL Intramuscularly as directed by physician, Walgreens Specialty Pharmacy, Fresco, TX.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1054-2013·2013-09-25

    Medaus Recalls Sodium Ascorbate Injection Due to Sterility Concerns

    Medaus, Inc. is recalling 15,500 mL of Sodium Ascorbate 500 mg/mL injection due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1051-2013·2013-09-25

    Medaus Recalls L-Glutathione Injection Due to Sterility Concerns

    Medaus, Inc. is recalling L-Glutathione 200 mg/mL PF, 100 mL, due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1053-2013·2013-09-25

    Medaus Recalls Magnesium Chloride Injection Due to Sterility Concerns

    Medaus, Inc. is recalling Magnesium Chloride 200 mg/mL PF, 100 mL vials due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    Magnesium Chl 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1049-2013·2013-09-25

    Medaus Recalls Lipo-Injection Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Lipo-Injection w/ Lidocaine because laboratory results indicate microbial contamination and sterility cannot be assured.

    Product
    Lipo-Injection w/ Lidocaine (PF), Ascorbic Acid 50 mg; B1-50 mg; B2-5-PO4-5 mg; B3-50 mg; B5-5 mg; B6-5 mg; Cyano B12-100 mcg; Methionine 12.5 mg; Inositol-25 mg; Choline-25 mg; Lidocaine 10 mg/mL, 30 mL, Medaus Pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1043-2013·2013-09-25

    JCB Labs Recalls Acetylcysteine Solution Due to Sterility Concerns

    JCB Labs LLC is recalling 903 vials of Acetylcysteine 20% Solution because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.

    Product
    Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1045-2013·2013-09-25

    JCB Labs Recalls Sodium Citrate Injection Due to Sterility Concerns

    JCB Labs LLC is recalling 397 vials of Sodium Citrate 4% with Gentamicin due to potential microbial contamination and unreliable sterility test results.

    Product
    Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1039-2013·2013-09-25

    Leiter's Pharmacy Recalls Hyaluronidase Vials Due to Sterility Concerns

    Leiter's Pharmacy is recalling 810 vials of Hyaluron (hyaluronidase) 150 units/mL due to bacterial contamination and unverified sterility.

    Product
    Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1059-2013·2013-09-25

    Avella Recalls Vancomycin and Bevacizumab Due to Sterility Concerns

    Avella Specialty Pharmacy is recalling vancomycin and bevacizumab products due to concerns about sterility assurance with its independent testing laboratory.

    Product
    Vancomycin PF (BSS) 1%, 1 mL, Avella Specialty Pharmacy, Phoenix, AZ 85085, 877-782-7684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1060-2013·2013-09-25

    Hydroxocobalamin Injection Recalled Due to Failed Sterility Testing

    Northern New England Compounding Pharmacy is recalling one lot of Hydroxocobalamin Injection because third-party testing failed to confirm sterility.

    Product
    Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States Compounding Pharmacy, Littleton, NH 03561
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1040-2013·2013-09-25

    Leiter's Pharmacy Recalls Bevacizumab Syringes Due to Sterility Concerns

    Leiter's Pharmacy is recalling 265 vials of compounded Bevacizumab (Avastin) because a testing lab reported failed sterility results as passing, making the product's sterility unassured.

    Product
    Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1055-2013·2013-09-25

    Medaus Recalls NA Ascorbate Injection Due to Sterility Concerns

    Medaus, Inc. is recalling NA Ascorbate 500 mg/mL injection due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1047-2013·2013-09-25

    JCB Labs Recalls Epinephrine Syringes Due to Sterility Concerns

    JCB Labs LLC is recalling 1,243 epinephrine syringes because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.

    Product
    Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Free/Sulfite Free, 1-mL Single-Use Syringe, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1046-2013·2013-09-25

    JCB Labs Recalls Sodium Citrate Injection Vials Due to Sterility Concerns

    JCB Labs LLC is recalling 677 vials of Sodium Citrate 4% Solution for Injection because laboratory results indicate microbial contamination and sterility cannot be assured.

    Product
    Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only, JCB Laboratories, Wichita, KS.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1050-2013·2013-09-25

    Medaus Recalls Taurine 50 mg/mL PF Due to Sterility Concerns

    Medaus, Inc. is recalling Taurine 50 mg/mL PF, 100 mL, due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    Taurine 50 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1041-2013·2013-09-25

    Leiter's Pharmacy Recalls Lidocaine/Phenylephrine Vials Due to Sterility Concerns

    Leiter's Pharmacy is recalling 728 vials of Lidocaine/Phenylephrine PF 1%/1.5% injectible solution because sterility cannot be assured after failed test results were incorrectly reported as passing.

    Product
    Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
    Category
    Drug
    Distribution
    Distributed nationwide