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.

276–300 of 1691

  • HighFDA (Drugs)·D-0285-2023·2023-02-22

    Intravenous hydration solution recalled for lack of sterility assurance

    Sentara Infusion Services is recalling D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML intravenous hydration solution due to lack of sterility assurance. Eight bags were dispensed to patients nationwide.

    Product
    D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML, Hydration, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0316-2023·2023-02-22

    Sodium Chloride Diluent Recalled Due to Sterility Assurance Failure

    Sentara Infusion Services is recalling Sodium Chloride 0.9% solution dispensed to patients nationwide due to lack of sterility assurance. The product was used as a diluent in home infusion therapy with Curlin or Sapphire pumps.

    Product
    Sodium Chloride 0.9 % (a) 100ML (MAGNESIUM) (b) 69.3ML, (c) 71.4ML, (d) 77.7ML, (e) 130ML, (f) 210ML, (g) 190ML, (h) 220ML: diluent, Rx Only, use with Curlin or Sapphire pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1116-2023·2023-02-22

    Surgical Convenience Kits Recalled Due to Non-Sterile Outer Wrapping

    MEDLINE surgical convenience kits are recalled due to a perforated outer bag that prevents the kit's outer wrapping from remaining sterile. Only the contents inside the wrapper are guaranteed sterile.

    Product
    Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Number DYNDA2489
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0304-2023·2023-02-22

    Methadone Syringes Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling methadone syringes due to lack of sterility assurance. The affected product was dispensed to patients nationwide.

    Product
    METHADONE (a) 2.5MG IN 5ML NS SYRINGE, (b) 4MG IN 5ML NS SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0274-2023·2023-02-22

    Ampicillin Injectable Solution Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling Ampicillin 12GM in NS 600M injectable solution due to lack of sterility assurance. The affected product was dispensed nationwide; patients should contact their healthcare provider.

    Product
    AMPICILLIN 12GM IN NS 600M, used with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1113-2023·2023-02-22

    Neonatal PICC Surgical Kits Recalled for Non-Sterile External Packaging

    Medline Industries is recalling CENTURION MEDICAL PRODUCTS neonatal PICC surgical kits because the perforated bag fails to maintain sterility on the exterior packaging. Only contents inside are sterile.

    Product
    Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC TRAY, Reorder Number CVI4685
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0323-2023·2023-02-22

    Vancomycin Intravenous Solution Recalled Due to Sterility Assurance Issue

    Sentara Infusion Services is recalling Vancomycin 700 MG and 1000 MG intravenous solution formulations due to lack of sterility assurance. Eighteen bags were distributed nationwide.

    Product
    VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0298-2023·2023-02-22

    INTRALIPID 18GM Parenteral Nutrition Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling 7 bags of INTRALIPID 18GM, a parenteral nutrition solution, due to lack of sterility assurance. The product was dispensed to patients nationwide.

    Product
    INTRALIPID 18GM, TPN, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2023·2023-02-22

    Medline Surgical Convenience Kits Recalled for Sterility Compromise

    Medline Industries is recalling 981 surgical convenience kits nationwide because the perforated outer bag does not maintain sterile conditions. Only the kit contents remain sterile, not the exterior wrapping.

    Product
    Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD; b) MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0297-2023·2023-02-22

    Antibiotic Injectable Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling an antibiotic injectable medication due to lack of sterility assurance. Seven bags were dispensed to patients nationwide with a Beyond Use Date of December 2022.

    Product
    IMIPENEM/CILASTATIN 2000MG IN NS 400ML, antibiotic, Rx Only, use with a Curlin Pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 63323-0322-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0281-2023·2023-02-22

    Cefoxitin injectable bags recalled nationwide for sterility assurance failure

    Cefoxitin injectable antibiotic (1GM and 2GM) prepared by Sentara Infusion Services is being recalled nationwide due to lack of sterility assurance. Affected patients should contact their pharmacy immediately.

    Product
    CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0273-2023·2023-02-22

    Amikacin Injectable Antibiotic Lacks Sterility Assurance, Nationwide Recall

    Sentara Infusion Services is recalling 7 bags of Amikacin 450MG injectable antibiotic due to lack of sterility assurance. The product was dispensed nationwide to patients receiving IV infusions.

    Product
    Amikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300 Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0301-2023·2023-02-22

    Levaquin 750MG Injectable Recalled Due to Lack of Sterility Assurance

    Sentara Infusion Services is recalling 14 bags of Levaquin 750MG injectable antibiotic dispensed nationwide due to lack of sterility assurance. The product was distributed to patients for home infusion pump use.

    Product
    Levaquin 750MG IN D5W 150ML, antibiotic, Rx Only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0322-2023·2023-02-22

    Vancomycin Injectable Bags Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling 155 bags of vancomycin injectable solution in multiple concentrations due to lack of sterility assurance. The product was dispensed nationwide for home infusion use.

    Product
    Vancomycin (a) 1.25GM IN NS 250ML, (b) 1.5GM IN NS 300ML, (c) 1000MG IN NS 200ML (d) 2GM IN 400ML NS, (e) 900MG IN NS 180ML, (f) 500 MG NS 100ML, (g) 750 MG NS 150ML, antibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0299-2023·2023-02-22

    KYTRIL Antiemetic Syringes Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling KYTRIL 350mcg syringes distributed nationwide due to lack of sterility assurance. Patients who received affected units should contact their healthcare provider.

    Product
    KYTRIL 350MCG IN 3.5ML NS SYRINGE, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0286-2023·2023-02-22

    Daptomycin Antibiotic Injectable Syringes Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling Daptomycin pre-filled syringes distributed nationwide due to lack of sterility assurance. Patients using this antibiotic should contact their healthcare provider immediately.

    Product
    DAPTOMYCIN (a)360MG in NS 18ML syringe (b)580MG IN NS 29ML syringe(c) 630MG IN NS 31.5ML used with a home pump; antibiotic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0287-2023·2023-02-22

    Daptomycin Injectable Antibiotic Recalled Due to Sterility Assurance Failure

    Sentara Infusion Services is recalling daptomycin injectable antibiotic bags due to lack of sterility assurance. The 17 affected bags were dispensed nationwide and pose a potential infection risk.

    Product
    DAPTOMYCIN (a) 400MG IN NS 20ML, (b) 550MG IN NS 27.5ML, antibiotic, Rx only, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1127-2023·2023-02-22

    Surgical Circumcision Kits Recalled Due to Non-Sterile Outer Wrapping

    MEDLINE INDUSTRIES is recalling CENTURION MEDICAL PRODUCTS Circumcision Tray kits (Lot 22HMH649) because the outer packaging is non-sterile, though the surgical contents inside remain sterile.

    Product
    Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISION TRAY, Reorder Number CIT3345
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0225-2023·2023-02-01

    Injectable NADH Recalled for Sterility Concerns at Manufacturing Facility

    Pharmacy Innovations is recalling NADH 10MG/ML injectable vials distributed nationwide due to lack of assurance of sterility. FDA inspection revealed insanitary conditions at the facility.

    Product
    NADH 10MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0240-2023·2023-02-01

    Antibiotic Eye Drops Recalled for Sterility Assurance Failure

    Pharmacy Innovations is recalling Tobramycin Fortified 15mg/mL Ophthalmic Solution nationwide due to insanitary facility conditions that compromised sterility assurance. Consumers should discontinue use and contact their healthcare provider.

    Product
    TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0213-2023·2023-02-01

    Injectable drug product recalled due to sterility assurance failure

    Pharmacy Innovations is recalling injectable glycerin/lidocaine/epinephrine products nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.

    Product
    GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 31%(V/V)/0.17%/0.00017% (10ML VIALS); GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 48.7%(W/V)/0.67%/0.00067% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0204-2023·2023-02-01

    Edetate Disodium Ophthalmic Solution Recalled for Sterility Concerns

    Pharmacy Innovations is recalling Edetate Disodium 1% ophthalmic solution nationwide due to insanitary facility conditions that compromised sterility assurance. No illnesses have been reported.

    Product
    EDETATE DISODIUM (VET) 1% (3ML droptainer) OPH Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0210-2023·2023-02-01

    Glutathione Injectable and Inhalation Products Recalled Due to Sterility Assurance Failure

    Pharmacy Innovations is recalling multiple glutathione products due to insanitary facility conditions that compromise sterility assurance. The recall affects inhalation and injectable formulations distributed nationwide.

    Product
    GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML (1ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 220MG/ML (30ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (1ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (2ML VIAL) INJECTABLE; GLUTATH
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0187-2023·2023-02-01

    Injectable Hydroxocobalamin Recalled Due to Sterility Assurance Failure

    Pharmacy Innovations is recalling Hydroxocobalamin 25MG/ML injectable vials nationwide due to insanitary facility conditions identified during FDA inspection that compromise sterility assurance.

    Product
    Hydroxocobalamin 25MG/ML (2ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0211-2023·2023-02-01

    FDA Recalls Injectable Glycerin 72% Due to Sterility Assurance Failure

    Pharmacy Innovations is recalling Injectable Glycerin 72% (15mL vials) nationwide due to lack of sterility assurance discovered during FDA facility inspection.

    Product
    GLYCERIN 72% (W/V) (15ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide