The Recall Desk

Hazard

Lack Of Sterility recalls

1,417 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,417
Critical
3
Severe
1,048
Most recent
2026-07-29

Of the 1,417 lack of sterility recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,048 (74%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all lack of 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.

251–275 of 1417

  • HighFDA (Drugs)·D-0199-2023·2023-02-01

    Clindamycin/EDTA Calcium Irrigation Solution Recalled for Lack of Sterility Assurance

    Pharmacy Innovations is recalling Clindamycin/EDTA Calcium irrigation solution (30ML syringe) distributed nationwide due to lack of assurance of sterility caused by insanitary conditions found during FDA inspection.

    Product
    Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0195-2023·2023-02-01

    Injectable ophthalmic drug recalled for sterility assurance failure

    FDA is recalling BSS Plus/Lidocaine Opth 1% injectable syringes manufactured by Pharmacy Innovations due to lack of sterility assurance found during a facility inspection.

    Product
    BSS Plus/Lidocaine Opth 1% (1ML syringe) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0216-2023·2023-02-01

    Ketamine 50mg/ml Injectable Vial Recalled for Sterility Concerns

    Pharmacy Innovations is recalling Ketamine 50mg/ml injectable vials nationwide due to insanitary facility conditions that compromised sterility assurance.

    Product
    KETAMINE 50MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0189-2023·2023-02-01

    Minoxidil injectable recalled due to lack of sterility assurance

    Pharmacy Innovations is recalling Minoxidil 0.75% injectable due to insanitary facility conditions identified during FDA inspection that could compromise product sterility.

    Product
    Minoxidil 0.75% (1.5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0232-2023·2023-02-01

    Ophthalmic solution recalled for lack of sterility assurance

    Pharmacy Innovations recalls a polyhexamethylene biguanide eye-drop solution nationwide due to insanitary manufacturing conditions. No illnesses have been reported.

    Product
    POLYHEXAMETHYLENE BIGUANIDE 0.2MG/ML (0.2%) (10ML DROPTAINER) OPTH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0202-2023·2023-02-01

    Injectable Drug Recall: Lack of Sterility Assurance at Manufacturing Facility

    Pharmacy Innovations is recalling an injectable medication due to lack of sterility assurance caused by insanitary conditions at the manufacturing facility. Affected vials were distributed nationwide.

    Product
    Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML (1ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0226-2023·2023-02-01

    FDA Recalls Papaverine/Phentolamine Injectable Vials Due to Sterility Concerns

    Pharmacy Innovations has recalled papaverine/phentolamine injectable vials in multiple concentrations due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.

    Product
    PAPAVERINE/PHENTOLAMINE 30MG/0.5MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/1MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/2MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/3MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/5MG/ML (1ML V
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0209-2023·2023-02-01

    Gentamicin Bladder Irrigation Solutions Recalled for Sterility Assurance Failure

    Pharmacy Innovations is recalling Gentamicin bladder irrigation solutions due to FDA findings of insanitary facility conditions that compromised sterility assurance during manufacturing.

    Product
    GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (30ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.64MG/ML (25ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.64MG/ML (25ML SYRINGE) IRRIGATION,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0227-2023·2023-02-01

    Injectable drug products recalled due to unsanitary manufacturing conditions

    Pharmacy Innovations is recalling injectable PE1/PAPAV/ATROP/CHLORPROM drugs due to insanitary facility conditions that compromise product sterility. FDA inspection found conditions that do not ensure the safety of these injectable medications.

    Product
    PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 100MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 15MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 30MCG/8.7MG/0.1MG/1.8MG/ML (
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0228-2023·2023-02-01

    Multiple injectable medications recalled for sterility assurance concerns

    Pharmacy Innovations recalls multiple injectable medications nationwide due to insanitary facility conditions compromising sterility assurance. FDA inspection revealed conditions creating risk to medication safety.

    Product
    PE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 30MCG/30MCG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 5.88MCG/17.65MG/0.588MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT (1ML) 10MCG/30MG/2MG/ML INJECTABLE PE1/PAPAV/PHENT 10MCG/18MG/1MG/ML (1ML VIAL) INJECTABL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0217-2023·2023-02-01

    LEVEMIR insulin injection recalled for lack of sterility assurance

    LEVEMIR injectable insulin is being recalled nationwide due to insanitary facility conditions that compromise sterility assurance. FDA inspection identified conditions that may affect product safety.

    Product
    LEVEMIR-STS- 100U/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0191-2023·2023-02-01

    FDA Recalls Acetylcysteine Ophthalmic Solution Due to Sterility Concerns

    Pharmacy Innovations is recalling Acetylcysteine 10% Ophthalmic Solution nationwide due to FDA-identified insanitary manufacturing conditions that compromise product sterility. Affected batches include codes t20221011@36 and t20221108@24.

    Product
    Acetylcysteine 10% Ophthalmic Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0223-2023·2023-02-01

    Mitomycin Ophthalmic Solution Recalled Nationwide Over Sterility Assurance

    Pharmacy Innovations is recalling Mitomycin 0.2mg/ml ophthalmic solution nationwide due to lack of sterility assurance following FDA facility inspection findings.

    Product
    MITOMYCIN 0.2MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.2MG/ML (1ML VIAL) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0212-2023·2023-02-01

    Injectable Glycerin Sterile Recalled for Lack of Sterility Assurance

    Pharmacy Innovations is recalling Glycerin Sterile 99% Injectable (2ML and 5ML vials) nationwide. FDA inspection revealed insanitary facility conditions that compromise the product's sterility assurance.

    Product
    GLYCERIN STERILE 99% 2ML VIAL and 5ML VIAL, Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0188-2023·2023-02-01

    Pharmacy Innovations Methylcobalamin Injectable Solutions Recalled for Sterility Concerns

    Pharmacy Innovations is recalling Methylcobalamin injectable solutions (1MG/ML, 3MG/ML, 5MG/ML vials) distributed nationwide. FDA inspection revealed insanitary conditions at the facility affecting product sterility assurance.

    Product
    Methylcobalamin 1MG/ML (1ML vial); Methylcobalamin 3MG/ML (1ML vial); Methylcobalamin 5MG/ML (1ML vial) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0186-2023·2023-02-01

    Injectable chlorpheniramine/hyoscyamine recalled for sterility assurance failure

    Pharmacy Innovations has recalled Chlorpheniramine/Hyoscyamine injectable medication nationwide due to insanitary facility conditions identified during FDA inspection that compromise product sterility.

    Product
    Chlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0241-2023·2023-02-01

    Vancomycin Ophthalmic Solutions Recalled for Sterility Assurance Concerns

    Pharmacy Innovations is recalling vancomycin fortified ophthalmic solutions nationwide due to lack of sterility assurance. FDA inspection revealed insanitary conditions at the manufacturing facility.

    Product
    VANCOMYCIN FORTIFIED 10MG/ML (1ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED 14MG/ML (3ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED-STS- 50MG/ML OPH SOLUTION VANCOMYCIN-STS- 25MG/ML (2ML DROPTAINER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0185-2023·2023-02-01

    Dutasteride Injectable Recalled for Lack of Sterility Assurance

    Pharmacy Innovations is recalling Dutasteride 0.1% injectable vials nationwide due to FDA-identified insanitary facility conditions that compromised sterility assurance. Patients should consult their healthcare provider about this prescription medication.

    Product
    Dutasteride 0.1% (1.5ML VIAL) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0111-2023·2023-01-18

    FDA Recalls Prostaglandin E1 Injection for Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling Prostaglandin E1 Injection Solution due to lack of sterility assurance. The recall affects 108 vials distributed nationwide.

    Product
    Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0115-2023·2023-01-18

    TriMix Injectable Medication Recalled for Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling TriMix Injection due to lack of sterility assurance. The injectable was distributed nationwide; affected patients should not use these vials and should contact their healthcare provider.

    Product
    TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0121-2023·2023-01-18

    TriMix Injection Recalled Nationwide for Lack of Sterility Assurance

    Northern VA Compounders recalls TriMix Injectable due to lack of sterility assurance in 8 vials distributed nationwide. Patients should consult their healthcare provider about affected doses.

    Product
    TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0108-2023·2023-01-18

    Compounded Injectable Drug Recalled Due to Lack of Sterility Assurance

    Northern VA Compounders has recalled QuadMix Super 002 injectable medication due to lack of assurance of sterility. The affected lot is distributed nationwide.

    Product
    QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0105-2023·2023-01-18

    Injectable drug recalled due to lack of sterility assurance

    Northern VA Compounders PLLC recalls compounded injectable QuadMix Super 001 (56 vials) nationwide due to lack of assurance of sterility. Affected lot #11162022@7, expiration 12/31/2022.

    Product
    QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0113-2023·2023-01-18

    TriMix Injection Recall Due to Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling TriMix Injection nationwide due to lack of assurance of sterility. The affected compounded injectable product comes in 2.5 mL vials with lot number 11142022@12.

    Product
    TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0104-2023·2023-01-18

    Compounded Injectable Medication Recalled Due to Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling QuadMix Standard 002 injectable medication because sterility of one lot cannot be assured. The recall affects 12 vials distributed nationwide.

    Product
    QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide