Hazard

Lack Of Sterility recalls

447 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 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.

276–300 of 447

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-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-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-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-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) I
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-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-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 VI
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 THIAMINE/RIBOFLAVIN/NIACINAMIDE/DEXPANTH
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-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-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-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-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-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-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-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-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-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
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-0050-2023·2022-11-09
Phentolamine Injectable Drug Recalled Due to Sterility Concerns
Pharmacy Plus recalls Phentolamine 10MG/ML injection due to lack of guaranteed sterility during production. Affected lots distributed to AL, LA, MS, and TN.
Product
PHENTOLAMINE 10MG/ML INJECTION, 10MG/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-0052-2023·2022-11-09
Prostaglandin E1 Injection Recalled Due to Sterility Assurance Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Prostaglandin E1 Injection Solution after FDA inspection found the products were manufactured in a manner that cannot guarantee sterility.
Product
PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/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-0033-2023·2022-11-09
Glycerin Ophthalmic Drops Recalled Due to Sterility Manufacturing Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Glycerin Ophthalmic Drops 98.5% Solution because manufacturing methods cannot guarantee the sterility of the product. Products affected are distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0057-2023·2022-11-09
Voriconazole ophthalmic solution recalled for sterility concerns
Pharmacy Plus, Inc. (Vital Care Compounder) is recalling Voriconazole Ophthalmic Solution 2% because FDA inspection found manufacturing processes cannot guarantee the product's sterility.
Product
VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states