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.

326–350 of 462

  • HighFDA (Drugs)·D-0054-2023·2022-11-09

    Pharmacy Plus Eye Solution Recalled for Sterility Assurance Issues

    Pharmacy Plus is recalling SERUM TEARS IN NSAL 20% Ophthalmic Solution due to lack of assurance of sterility. FDA inspection found the manufacturing process could not guarantee the product's sterility.

    Product
    SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0038-2023·2022-11-09

    Methylcobalamin Injection Recalled for Lack of Sterility Assurance

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 514 vials of methylcobalamin injection solution. FDA inspection found manufacturing conditions that do not assure sterility.

    Product
    METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0049-2023·2022-11-09

    Prescription Injectable Medication Recalled for Sterility Assurance Failure

    Pharmacy Plus, Inc. recalled a prescription injectable medication (Papaverine/Phentolamine/Prostaglandin) because FDA inspection found the product was produced in a manner that cannot guarantee sterility. Lot 65976 (BUD 10/27/2022) was distributed in AL, LA, MS, and TN.

    Product
    PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0056-2023·2022-11-09

    FDA Recalls Vancomycin Intravitreal Injections for Sterility Defect

    Pharmacy Plus Inc. is recalling vancomycin intravitreal eye injections due to FDA findings that sterility cannot be assured. The products were produced in a manner that does not guarantee they remain sterile.

    Product
    VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0034-2023·2022-11-09

    Laureth-9 Injectable Solution Recalled for Lack of Sterility Assurance

    A compounded Laureth-9 injectable solution has been recalled after the FDA found the manufacturing process could not guarantee sterility. The recalled product (lot 66513) was distributed in AL, LA, MS, and TN.

    Product
    LAURETH-9 INJ 2% Solution, 30 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0028-2023·2022-11-09

    FDA Recalls Vital Care Autologous Tears Serum Due to Sterility Assurance Failure

    Vital Care Compounder's Autologous Tears Serum Full Strength has been recalled due to manufacturing defects that cannot assure product sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0047-2023·2022-11-09

    Papaverine HCL Stock Solution Recalled Due to Sterility Assurance Failure

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Papaverine HCL Stock Solution 30mg/ml vials due to lack of sterility assurance. FDA inspection found the product was produced in a manner that cannot guarantee sterility.

    Product
    PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0042-2023·2022-11-09

    Pharmacy Plus Injectable Drug Recall Due to Sterility Assurance Failure

    Pharmacy Plus, Inc. recalled a compounded injectable medication (56 vials) due to manufacturing processes that cannot guarantee product sterility. Distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0037-2023·2022-11-09

    Injectable hormone medication recalled for sterility assurance failure

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Medroxyprogesterone Acetate 300 mg/mL suspension due to lack of sterility assurance. The product was produced in a manner that cannot guarantee sterility of the injectable medication.

    Product
    MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0046-2023·2022-11-09

    Injectable Papaverine/Phentolamine Recalled Due to Sterility Assurance Failure

    Pharmacy Plus, Inc. is recalling 242 vials of papaverine/phentolamine injection because FDA inspection found the products were produced in conditions that cannot guarantee sterility. The affected lots were distributed to AL, LA, MS, and TN.

    Product
    PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-1779-2022·2022-10-05

    SunMed Pulset Syringes Recalled Due to Non-Sterile Spare Needles

    SunMed Holdings is recalling Pulset 3cc syringes with non-sterile spare needles that could cause skin infection or sepsis if used. The recall affects 53,560 units distributed across ten US states.

    Product
    Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Drugs)·D-1531-2022·2022-09-21

    Injectable drug recalled due to lack of sterility assurance

    Carolina Infusion is recalling TRI-MIX 30/2/40 Injectable because the manufacturer cannot assure the product's sterility. Non-sterile injectable drugs pose serious infection risks.

    Product
    TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1518-2022·2022-09-21

    Sermorelin Acetate Injectable Recalled Due to Lack of Sterility Assurance

    Carolina Infusion is recalling Sermorelin Acetate injectable (1 MG/ML, 9 ML syringes) distributed nationwide due to lack of assurance of sterility. The manufacturer could not adequately document that the product meets required sterility standards.

    Product
    Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1521-2022·2022-09-21

    Semaglutide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Failure

    Carolina Infusion is recalling Semaglutide/Cyanocobalamin injectable syringes nationwide due to lack of assurance of sterility. Patients using Lot 08172022@1 should contact their healthcare provider immediately.

    Product
    Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1528-2022·2022-09-21

    TRI-MIX 30/1/40 Injectable Recalled Due to Lack of Sterile Assurance

    Carolina Infusion is recalling TRI-MIX 30/1/40 Injectable due to lack of assurance of sterility. Affected lots were distributed nationwide and pose risk of infection.

    Product
    TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1532-2022·2022-09-21

    TRI-MIX 50/2.5/25 Injectable recalled for lack of sterility assurance

    Carolina Infusion is recalling TRI-MIX 50/2.5/25 Injectable (Lot 07052022@2) nationwide due to lack of assurance of sterility. Patients should not use affected vials and should consult their healthcare provider.

    Product
    TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1707-2022·2022-09-21

    Roadrunner PC Hydrophilic Wire Guide Recalled Due to Packaging Integrity Failure

    Cook Incorporated is recalling 2,407 units of Roadrunner PC Hydrophilic Wire Guide due to failed packaging integrity testing that may compromise device sterility. No illnesses or injuries have been reported.

    Product
    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1515-2022·2022-09-21

    L-Carnitine Injectable Recalled Due to Sterility Assurance Failure

    Carolina Infusion is recalling L-Carnitine 500 mg/mL injectable vials nationwide due to lack of assurance of sterility. The affected lot 06132022@17 should not be administered.

    Product
    L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1514-2022·2022-09-21

    Injectable Anesthetic Solution Recalled for Lack of Sterility Assurance

    Pine Pharmaceuticals is recalling Bupivacaine and Lidocaine injectable solutions for eye anesthesia due to lack of assurance of sterility. The product was distributed to direct accounts in four states.

    Product
    Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6919409331, Rx only, Pine Pharmaceuticals, 355 Riverwalk Park
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-1534-2022·2022-09-21

    FDA Recalls QUAD-MIX Injectable for Sterility Assurance Failure

    Carolina Infusion recalls QUAD-MIX injectable (Lot 08082022@3) nationwide due to lack of sterility assurance, a critical safety requirement for injectable medications.

    Product
    QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1496-2022·2022-09-14

    Sodium Chloride Ophthalmic Ointment Recalled for Turbidity and Sterility Concerns

    Akorn, Inc. is recalling Sodium Chloride Ophthalmic Ointment due to turbidity found during sterility testing. The FDA expanded the recall to additional lots sharing potential root cause.

    Product
    Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1259-2022·2022-07-27

    Ketamine HCl Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling Ketamine HCl Injection due to lack of sterility assurance. The recall affects 91,445 pre-filled syringes distributed nationwide.

    Product
    Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1264-2022·2022-07-27

    Lidocaine HCl injection syringes recalled due to sterility assurance failure

    Nephron Sterile Compounding Center has recalled 37,310 syringes of Lidocaine HCl Injection USP 1% nationwide due to lack of assurance of sterility. Affected lots expire between August and October 2022.

    Product
    Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-985-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1276-2022·2022-07-27

    Nephron Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection (1 mg/10 mL) syringes nationwide due to inability to guarantee sterility. Approximately 464,265 syringes across eleven lot numbers are affected.

    Product
    Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1407-2022·2022-07-27

    Nonsterile Components in Medical Convenience Kits Recalled

    ROi CPS LLC is recalling 86 nonsterile medical convenience kits distributed in Missouri because components that were supposed to be sterile were packaged as nonsterile.

    Product
    Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
    Category
    Medical Device
    Distribution
    1 state