The Recall Desk

Hazard

Lack Of Sterility recalls

1,423 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,423
Critical
3
Severe
1,055
Most recent
2026-10-14

Of the 1,423 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 1,055 (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 1423

  • 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-0236-2023·2023-02-01

    Semaglutide Injectable Vials Recalled for Lack of Sterility Assurance

    Pharmacy Innovations is recalling Semaglutide injectable vials in multiple strengths distributed nationwide due to insanitary facility conditions compromising sterility. No illnesses have been reported.

    Product
    SEMAGLUTIDE 0.5MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 1MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 2MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 4MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 5.4MG/ML (0.5ML VIAL) INJECTABLE, 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-0203-2023·2023-02-01

    Edetate Calcium Disodium Injectable Recalled for Sterility Assurance Concerns

    Pharmacy Innovations is recalling Edetate Calcium Disodium 400MG/ML injectable vials nationwide due to insanitary manufacturing conditions that compromise sterility assurance.

    Product
    Edetate Calcium Disodium 400MG/ML (30ML 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-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-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-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-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)…
    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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0197-2023·2023-02-01

    Ceftazidime Injectable Recalled for Lack of Sterility Assurance

    Pharmacy Innovations is recalling Ceftazidime Intravitreal injectable nationwide due to lack of sterility assurance identified during FDA inspection of the manufacturing facility.

    Product
    Ceftazidime Intravitreal (1ML vial) 22.5 MG/ML(2.25MG/0.1ML) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0193-2023·2023-02-01

    Pharmacy Innovations Apomorphine Injectable Recalled for Sterility Assurance Failure

    Pharmacy Innovations is recalling Apomorphine HCL 2MG/ML injectable vials nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.

    Product
    Apomorphine HCL 2MG/ML (10ML 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-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-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-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-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-0190-2023·2023-02-01

    5-Fluorouracil Ophthalmic Solution Recalled for Sterility Assurance Concerns

    Pharmacy Innovations is recalling 5-Fluorouracil 1% ophthalmic solution nationwide due to lack of sterility assurance. An FDA inspection found insanitary conditions at the manufacturing facility.

    Product
    5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0231-2023·2023-02-01

    Pharmacy Innovations polidocanol injectable vials recalled for lack of sterility

    Pharmacy Innovations is recalling polidocanol injectable vials nationwide after FDA inspection revealed insanitary conditions at the manufacturing facility that compromised sterility assurance.

    Product
    POLIDOCANOL 50MG/ML (5%) (30ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0206-2023·2023-02-01

    Pharmacy Innovations recalls injectable estradiol and testosterone products nationwide for sterility assurance

    Pharmacy Innovations recalls multiple injectable estradiol and testosterone products due to insanitary facility conditions that compromise sterility assurance. The products were distributed nationwide.

    Product
    ESTRADIOL CYP/TEST CYP- SS OIL- 2MG/50MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP/TEST CYP -SS OIL- 2MG/25MG/ML (1ML VIAL) INJECTABLE; ESTRADIOL CYP-CS OIL- 5MG/ML (1.25ML VIAL) INJECTABLE; ESTRADIOL CYP-GS OIL- 5MG/ML (1ML VIAL) INJECTABLE ESTRADIOL CYP-SS OIL- 5MG/ML (1.5ML…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0239-2023·2023-02-01

    Injectable vitamin B-complex products recalled for lack of sterility assurance

    Pharmacy Innovations is recalling three injectable vitamin B-complex products nationwide due to insanitary conditions discovered during FDA inspection. The products lack assurance of sterility and may pose contamination risk.

    Product
    THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL 25MG/25MG/25MG/25MG/25MG/20MG/ML (3ML VIAL) INJECTABLE THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/METHYLFOLATE/METHYLCOBAL 10MG/2.5MG/25MG/5MG/5MG/10MG/10MG/ML (1ML VIAL) INJECTABLE…
    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-0238-2023·2023-02-01

    Pharmacy Innovations Testosterone Injectables and Ophthalmic Products Recalled for Sterility Concerns

    Pharmacy Innovations is recalling multiple testosterone injectable and ophthalmic formulations nationwide due to insanitary facility conditions that prevent assurance of sterile manufacturing.

    Product
    TESTOSTERONE 3% (4GM TUBE) OPHTH OINTME TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/0.5MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (3ML VIAL) INJECTABLE TESTOSTERONE…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0234-2023·2023-02-01

    Injectable Prostaglandin E1 Multiple Strengths Recalled for Sterility Concerns

    Pharmacy Innovations is recalling multiple strengths of injectable Prostaglandin E1 nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.

    Product
    PROSTAGLANDIN (PE1) 45MCG (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 17MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 20MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 22.5MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 23MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 30MCG/ML (1ML VIAL)…
    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