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.

1401–1425 of 1691

  • SevereFDA (Drugs)·D-1102-2014·2014-03-12

    Bleomycin Sulfate Recalled Due to Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all non-expired lots of Bleomycin Sulfate 1unit/ml due to quality control issues affecting sterility assurance.

    Product
    Bleomycin Sulfate 1unit/ml
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1119-2014·2014-03-12

    Greatbatch Medical Recalls Offset Cup Impactor Due to Sterility Assurance Concerns

    Greatbatch Medical is recalling Standard Offset Cup Impactors because internal testing showed the specified sterilization cycles may not achieve the required sterility assurance level.

    Product
    Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340, T12121, T12230, T12288, T12305, T12391, T12699, T12767, T12861, T13344, T13480, T13642, T13722, T13999, T14155, T14384,
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Drugs)·D-1066-2014·2014-02-12

    Apothecure Recalls Sterile Compounded Products Due to Sterility Assurance Concerns

    Apothecure, Inc. is recalling all lots of sterile compounded products within expiry due to lack of sterility assurance identified during an FDA inspection.

    Product
    The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1040-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling several Rohto eye drop products due to concerns about the quality assurance of sterility controls.

    Product
    ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, Lubricant, Redness Reliever Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01099 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1039-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling several Rohto eye drop products due to concerns about the quality assurance of sterility controls.

    Product
    ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01096 1, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1038-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling Rohto eye drops because of concerns about the quality assurance of sterility controls.

    Product
    ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01086 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1051-2014·2014-02-05

    NuVision Pharmacy Recalls HCG Vials Due to Sterility Assurance Concerns

    NuVision Pharmacy is recalling 285 vials of HCG (Lyophilized) nationwide due to a lack of sterility assurance identified during an FDA inspection.

    Product
    HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1035-2014·2014-02-05

    Hospira Recalls Aminosyn 3.5% Bags Due to Sterility Concerns

    Hospira Inc. is recalling 15,258 bags of Aminosyn 3.5% M Sulfite-Free due to a lack of assurance of sterility and potential leakage from the administrative port.

    Product
    Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-423-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Glutathione PF Inhalation Solution

    Specialty Medicine Compounding Pharmacy is recalling Glutathione PF inhalation solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-453-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Triple Mix Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Triple Mix injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverine hydrochloride, phentolamine, prostaglandin), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-435-2014·2014-01-22

    Neomycin Sulfate Ophthalmic Solution Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Neomycin Sulfate ophthalmic solution because sterility cannot be assured after a related product was found non-sterile.

    Product
    Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-413-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Ceftazidime Ophthalmic Solution

    Specialty Medicine Compounding Pharmacy is recalling Ceftazidime ophthalmic solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    Ceftazidime, 22.5 mg/ml (ophthalmic), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-420-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Fluconazole and Gentamicin Solution

    Specialty Medicine Compounding Pharmacy is recalling fluconazole and gentamicin solution because sterility cannot be assured after a related product was found non-sterile.

    Product
    FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-460-2014·2014-01-22

    Sodium Hydroxide Solution Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Sodium Hydroxide 10% Solution because sterility cannot be assured after a related product was found non-sterile.

    Product
    SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-456-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls WB-Tranexamic Acid Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling WB-Tranexamic acid products because sterility cannot be assured after a related product was found to be non-sterile.

    Product
    WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) TOPICAL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0779-2014·2014-01-22

    Anspach MIA 16 Minimally Invasive Attachment Recalled for Sterility Failure

    The Anspach Effort, Inc. is recalling 183 Anspach MIA 16 attachments because they did not reach the expected sterility assurance level.

    Product
    Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0771-2014·2014-01-22

    Teleflex Recalls Electrosurgical Coagulation Suction Tubes Due to Sterility Concerns

    Teleflex Medical is recalling 17,450 electrosurgical coagulation suction tubes because sterility cannot be guaranteed. The devices are distributed nationwide.

    Product
    Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 27709. Intended to remove tissue and control bleeding by use of high-frequency electrical current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2014·2014-01-08

    Zimmer Recalls ITST Threaded Guide Pins Due to Sterility Concerns

    Zimmer, Inc. is recalling ITST Threaded Guide Pins because testing found that a specific packaging tray configuration failed to maintain sterile barrier integrity.

    Product
    ITST THREADED GUIDE PIN
    Category
    Medical Device
    Distribution
    0 states