The Recall Desk

Hazard

Sterility Failure recalls

462 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

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 462

  • HighFDA (Drugs)·D-0636-2023·2023-05-24

    Vancomycin injection recalled for lack of sterility assurance

    Vancomycin 1.5g in 0.9% saline solution being recalled due to lack of assurance of sterility. Product distributed in Missouri with lot numbers AC-016629 and AC-016646.

    Product
    VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0598-2023·2023-05-24

    Ampicillin and Sulbactam Injection Recalled Over Sterility Assurance Failure

    The FDA is recalling 11,555 bottles of Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The nationwide recall affects all lots within expiry.

    Product
    Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-208-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0634-2023·2023-05-24

    Fentanyl Injectable Syringes Recalled for Lack of Sterility Assurance

    Apollo Care's fentanyl 50 mcg/mL injectable syringes are recalled due to lack of assurance of sterility. The 790-syringe batch distributed in Missouri may pose contamination risks if administered.

    Product
    FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-910-25
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0625-2023·2023-05-24

    Piperacillin and Tazobactam Injection Recalled for Sterility Assurance Failure

    Meitheal Pharmaceuticals is recalling Piperacillin and Tazobactam for Injection due to lack of sterility assurance. The recalled product may pose an infection risk to patients if used.

    Product
    Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0591-2023·2023-05-24

    Injectable Antibiotic Ampicillin and Sulbactam Recalled Over Sterility Concerns

    Ampicillin and Sulbactam for Injection lacks assurance of sterility, posing potential infection risk. The FDA is recalling 419,680 vials distributed nationwide.

    Product
    Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0538-2023·2023-04-26

    Compounded Semaglutide Injection Recalled Due to Sterility Assurance Failure

    Vital Care Compounder is recalling C-Semaglutide 5mg/mL injection in 0.5mL vials due to lack of assurance of sterility. The recall affects 45 vials distributed in Mississippi.

    Product
    C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0355-2023·2023-03-08

    Diltiazem HCl Injectable Drug Recalled for Sterility Assurance Failure

    Nephron Sterile Compounding Center is recalling Diltiazem HCl injectable due to lack of sterility assurance. The FDA Class II recall affects 4,743 bottles distributed nationwide.

    Product
    Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0358-2023·2023-03-08

    Injectable Norepinephrine Recalled Nationwide for Sterility Assurance Failure

    FDA recalls norepinephrine bitartrate injection (270,291 bottles nationwide) due to lack of sterility assurance. The injectable medication from Nephron Sterile Compounding Center poses infection risk if used.

    Product
    Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-315-25.
    Category
    Drug
    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 (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 (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-0300-2023·2023-02-22

    Lactated Ringers IV Solution Recalled for Sterility Assurance Failure

    Sentara Infusion Services is recalling Lactated Ringers IV solutions (NDC 00338-0117-03) due to lack of sterility assurance. The recall affects 25 bags dispensed nationwide with a Beyond Use Date of December 24-31, 2022.

    Product
    Lactated Ringers packaged in volume of 1000ML, 2500ML, 3000 ML, 3600 ML, 500ML (NDC 00338-0117-03)hydration, Rx Only, use with Curlin 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-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-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-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
  • 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-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-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 (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-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 (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-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-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