Hazard

Sterility Failure recalls

1,693 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,693
Critical: 12
Severe: 938
Most recent: 2026-09-30

Of the 1,693 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 938 (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 1693

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-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-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-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-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-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-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 (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-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…
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 (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-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-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-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-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 (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-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-0222-2023·2023-02-01
Methylcobalamin Injectable Recall Due to Facility Sterility Assurance Failure
Pharmacy Innovations is recalling injectable methylcobalamin products in multiple strengths due to lack of sterility assurance. FDA inspection revealed insanitary facility conditions that compromise product safety.
Product
METHYLCOBALAMIN 12.5MG/ML (1ML VIAL) INJECTABLE METHYLCOBALAMIN 25MG/ML (1.2ML VIAL) INJECTABLE; METHYLCOBALAMIN 3MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN 5MG/ML (0.2ML VIAL) INJECTABLE; METHYLCOBALAMIN 5MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN-PF- 12.5MG/ML (1ML VIAL)…
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-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-0208-2023·2023-02-01
Flurbiprofen eye drops recalled for insanitary facility conditions
Pharmacy Innovations is recalling Flurbiprofen 0.04% ophthalmic solution nationwide due to insanitary conditions at the manufacturing facility that compromise product sterility.
Product
FLURBIPROFEN -CORN OIL- 0.04% (3ML DROPTAINER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0243-2023·2023-02-01
FDA Recalls Voriconazole Ophthalmic Solution for Sterility Assurance Failure
Pharmacy Innovations is recalling Voriconazole 10mg/ml ophthalmic solution nationwide because FDA inspection found insanitary facility conditions that compromised product sterility assurance.
Product
VORICONAZOLE 10MG/ML (10ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide