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.

1076–1100 of 2383

  • SevereFDA (Drugs)·D-0178-2017·2016-12-14

    North American Rescue Recalls Advance Trauma Kits Due to Sterility Concerns

    North American Rescue LLC is recalling Advance Trauma Kits because the manufacturer has concerns regarding the sterility of the eye wash irrigating solution.

    Product
    Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0179-2017·2016-12-14

    North American Rescue Recalls K-9 Trauma Field Kits Due to Sterility Concerns

    North American Rescue LLC is recalling K-9 Trauma Field Kits because the manufacturer has concerns about the sterility of the included eye wash irrigating solution.

    Product
    K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0176-2017·2016-12-14

    North American Rescue Recalls Range Trauma Kits Due to Sterility Concerns

    North American Rescue is recalling specific Range Trauma Kits because the manufacturer has concerns about the sterility of the included eye wash solution.

    Product
    Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0678-2017·2016-12-07

    Teleflex Recalls OnControl Biopsy System Ported Needle Trays for Sterility Concerns

    Teleflex Medical is recalling OnControl Biopsy System Ported Needle Trays due to a potential incomplete seal on the outer sterile package.

    Product
    OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow cor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0154-2017·2016-12-07

    Par Pharmaceutical Recalls Travoprost Ophthalmic Solution Due to Sterility Concerns

    Par Pharmaceutical is recalling specific lots of Travoprost Ophthalmic Solution because the dropper tips may be damaged, compromising sterility.

    Product
    Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by: Par Pharmaceutical Cos., Inc, Spring Valley, NY 10977
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0679-2017·2016-12-07

    Teleflex Recalls Arrow OnControl Aspiration System Trays Due to Sterility Concerns

    Teleflex Medical is recalling specific lots of Arrow OnControl Ported Aspiration System Trays because the outer sterile package may have an incomplete seal.

    Product
    ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0153-2017·2016-11-30

    Hospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips

    Hospira is recalling specific lots of Fentanyl Citrate Injection ampules because broken tips may compromise sterility.

    Product
    Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0015-2017·2016-10-19

    Leiter's Compounding Recalls Mitomycin Injection Due to Sterility Concerns

    Leiter's Compounding is recalling Mitomycin 0.02% injections because the filters used to produce them were recalled, raising concerns about sterility.

    Product
    Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0018-2017·2016-10-19

    Leiter's Compounding Recalls Vancomycin Injection Due to Sterility Concerns

    Leiter's Compounding is recalling Vancomycin 10 mg/mL injection vials because they were produced using recalled filters, raising concerns about sterility.

    Product
    Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0014-2017·2016-10-19

    FDA Recalls Lidocaine and Phenylephrine Injection Due to Sterility Concerns

    Leiter's Compounding is recalling Lidocaine HCl and Phenylephrine HCl injection vials because they were produced using recalled filters, raising concerns about sterility.

    Product
    Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-002-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0016-2017·2016-10-19

    Leiter's Compounding Recalls Moxifloxacin Intravitreal Injection Due to Sterility Concerns

    Leiter's Compounding is recalling Moxifloxacin intravitreal injections because they were produced using recalled filters, raising concerns about sterility.

    Product
    Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0012-2017·2016-10-19

    Leiter's Compounding Recalls Cefuroxime Sodium Injection Due to Sterility Concerns

    Leiter's Compounding is recalling Cefuroxime Sodium Injection because products were made with recalled filters, raising sterility concerns.

    Product
    Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0002-2017·2016-10-12

    Methylcobalamin Injection Recalled Due to Sterility Assurance Issues

    The Apothecary Shoppe LLC is recalling Methylcobalamin 5000 mcg/mL Injection in Oklahoma because the medication was sterilized with a recalled filter.

    Product
    Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1539-2016·2016-10-05

    Morphine Sulfate Injection Recalled for Lack of Sterility Assurance

    Pharmacy Plus, Inc. is recalling Morphine Sulfate 15mg/ml Injection due to a lack of assurance of sterility. The product was distributed in Mississippi.

    Product
    Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1538-2016·2016-10-05

    Vital Care Compounder Recalls Moxifloxacin HCl Eye Drops for Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 16 vials of Moxifloxacin HCl eye drops due to a lack of assurance of sterility.

    Product
    Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial, Rx, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1544-2016·2016-10-05

    FDA Recalls Hydroxyzine HCl Injection Due to Sterility Concerns

    Pharmacy Plus, Inc. is recalling 139 vials of Hydroxyzine HCl injection in Mississippi due to a lack of assurance of sterility.

    Product
    Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1532-2016·2016-10-05

    Vital Care Compounder Recalls Moxifloxacin and Dexamethasone Eye Drops

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling specific lots of Moxifloxacin and Dexamethasone ophthalmic vials due to a lack of assurance of sterility.

    Product
    Moxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/ml, Dexamethasone Sodium Phosphate 1mg/ml, Rx only, For ophthalmic use only, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1546-2016·2016-10-05

    Vital Care Compounder Recalls Olopatadine Eye Drops for Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Olopatadine 0.8% Ophthalmic Solution due to a lack of assurance of sterility.

    Product
    Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1529-2016·2016-10-05

    Vital Care Compounder Recalls Chlorpheniramine Maleate Due to Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 108 vials of Chlorpheniramine Maleate 10 mg/ml due to lack of assurance of sterility.

    Product
    Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1541-2016·2016-10-05

    FDA Recalls Autologous Serum Tears Due to Sterility Assurance Concerns

    The FDA is recalling Autologous Serum Tears from Vital Care Compounder due to a lack of assurance of sterility. The product was distributed in Mississippi.

    Product
    Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1535-2016·2016-10-05

    FDA Recalls Vital Care Compounder Papaverine and Prostaglandin Vials for Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling specific lots of Papaverine and Prostaglandin vials due to a lack of assurance of sterility.

    Product
    Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1547-2016·2016-10-05

    FDA Recalls Vital Care Compounder Injection Due to Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling C-PAP/PHEN/PROST/Atrop 150/7.5 injection vials due to a lack of assurance of sterility.

    Product
    C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin 75mcg/Atropine 1mg injection), 10 ml vial containing 5.9ml solution, Rx, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1512-2016·2016-09-28

    The Apothecary Recalls Prostaglandin and Other Medications Due to Sterility Concerns

    The Apothecary is recalling specific lots of Prostaglandin and other medications due to a lack of assurance of sterility and unsubstantiated validation of beyond-use dating.

    Product
    Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
    Category
    Drug
    Distribution
    1 state