The Recall Desk

Hazard

Non Sterility recalls

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

What the numbers show

Total
145
Critical
85
Severe
55
Most recent
2026-07-01

Of the 145 non sterility recalls we have scored against our rubric, 85 (59%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 55 (38%) 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 non 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.

51–75 of 145

  • SevereFDA (Drugs)·D-0718-2021·2021-08-18

    Compounded Progesterone Oil Recalled for Non-Sterility Risk

    People's Custom Rx is recalling C-Progesterone Oil 100 mg/mL compounded vials due to non-sterility concerns. The recall affects 14 vials distributed in Mississippi and Tennessee.

    Product
    C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only, People's Custom Rx, 785 E Brookhaven Cir, Memphis, TN 38117
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0710-2021·2021-08-18

    Morphine-Bupivacaine Injectable Recalled for Non-Sterility

    Med Shop Total Care Inc. is recalling morphine-bupivacaine injectable in prefilled syringes of multiple strengths due to non-sterility. The affected product was distributed to Texas and Puerto Rico.

    Product
    MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes in various strengths: a) 20MG/ML-40MG/ML, b) 15MG-30MG/ML, c) 5MG/ML-20MG/ML, d) 2MG-30MG/ML, e) 20MG-5MG/ML, f) 15MG-5MG/ML, g) 5MG-2MG/ML, h) 5MG-11MG/ML, i) 20MG-6MG/ML, j) 10MG-10MG/ML, k) 6MG-4.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0714-2021·2021-08-18

    Injectable Drug Sufentanil-Bupivacaine-Baclofen Recalled for Non-Sterility

    Med Shop Total Care Inc. is recalling a 41 mL injectable drug combination due to non-sterility concerns. The affected product was distributed in Texas and Puerto Rico.

    Product
    SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0708-2021·2021-08-18

    Injectable Drug Syringes Recalled for Non-Sterility

    Med Shop Total Care is recalling injectable drug syringes containing hydromorphone, bupivacaine, and baclofen due to non-sterility. The affected products were distributed in Texas and Puerto Rico.

    Product
    HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) 2MG-1MG-10MCG/ML, d) 10MG-5MG-10MCG/ML, e) 15MG-5MG-2000MCG/ML, f) 8MG-10MG-400MCG/ML, Rx only, Med Shop Total Care 470 East Loop
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0706-2021·2021-08-18

    Fentanyl-Bupivacaine Injectable Recalled for Non-Sterility Risk

    Med Shop Total Care is recalling one lot of Fentanyl-Bupivacaine HCL PF Injectable due to non-sterility concerns. The affected product was distributed in Texas and Puerto Rico.

    Product
    FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0712-2021·2021-08-18

    Injectable morphine-hydromorphone-bupivacaine mixture recalled for non-sterility

    Med Shop Total Care Inc. is recalling a compounded injectable pain medication in Texas and Puerto Rico because the product failed to meet sterility standards. The recall affects lot 09292020@64.

    Product
    MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop 470 E. Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0713-2021·2021-08-18

    Morphine-Bupivacaine-Ketamine Injectables Recalled for Non-Sterility

    Med Shop Total Care Inc. is recalling Morphine-Bupivacaine-Ketamine PF Injectable syringes distributed in Texas and Puerto Rico due to non-sterility. The injectable comes in two strengths in 21 mL syringes and is available by prescription only.

    Product
    MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0711-2021·2021-08-18

    Injectable Drug Recall: Non-Sterile Hydromorphone-Bupivacaine-Fentanyl

    Med Shop Total Care is recalling injectable syringes containing hydromorphone, bupivacaine, and fentanyl due to non-sterility concerns. The recall affects products distributed in Texas and Puerto Rico.

    Product
    HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c) 13.3MG-3MG-3000MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0716-2021·2021-08-18

    Injectable Drug Recalled for Non-Sterility Risk

    Med Shop Total Care Inc. is recalling a compounded injectable drug containing hydromorphone, bupivacaine, and sufentanil due to non-sterility concerns. The drug was distributed in Texas and Puerto Rico.

    Product
    HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0709-2021·2021-08-18

    Injectable drug recalled for non-sterility concerns in Texas and Puerto Rico

    Med Shop Total Care is voluntarily recalling injectable hydromorphone HCL-bupivacaine HCL-clonidine HCL due to non-sterility. The recall affects specific lots distributed in Texas and Puerto Rico.

    Product
    HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two strengths: a) 20MG-20MG-60MCG/ML INJECTABLE, b) 5MG-5MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0343-2021·2021-05-05

    FDA Recalls Chloraprep One-Step Antiseptic Due to Fungal Contamination

    CareFusion 213, LLC is recalling Chloraprep One-Step antiseptic applicators because fungal growth breached package integrity. The product is distributed nationwide and internationally.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0344-2021·2021-05-05

    ChloraPrep One-Step Recalled for Fungal Contamination and Package Breach

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because fungal growth breached package integrity. The product is a sterile skin antiseptic.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0265-2021·2021-03-03

    FDA Recalls Chloraprep One-Step Due to Potential Fungal Growth

    CareFusion 213, LLC is recalling Chloraprep One-Step applicators distributed in Puerto Rico and Oman due to potential fungal growth in hot, humid conditions.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0268-2021·2021-03-03

    FDA Recalls Chloraprep One-Step Antiseptic Due to Non-Sterility Risk

    CareFusion 213, LLC is recalling 400 cartons of Chloraprep One-Step antiseptic applicators distributed in Puerto Rico and Oman due to potential fungal growth and package integrity breaches.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1509-2020·2020-08-26

    FDA Recalls Chloraprep One-Step Applicators Due to Non-Sterility

    CareFusion 213, LLC is recalling 12,500 units of Chloraprep One-Step applicators because they are not sterile and contain Aspergillus Penicilloides.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1510-2020·2020-08-26

    CareFusion Recalls ChloraPrep Applicators Due to Non-Sterility

    CareFusion is recalling ChloraPrep With Tint applicators because they are not sterile and contain Aspergillus Penicilloides.

    Product
    ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1511-2020·2020-08-26

    CareFusion Chlorhexidine Applicators Recalled for Non-Sterility

    CareFusion 213, LLC is recalling ChlroraPrep One-Step applicators due to the presence of Aspergillus Penicilloides.

    Product
    ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1398-2019·2019-06-19

    Heritage Pharmaceuticals Recalls Amikacin Sulfate Injection Due to Microbial Growth

    Heritage Pharmaceuticals is recalling Amikacin Sulfate Injection vials because microbial growth was detected in a sub-lot. The affected product is distributed nationwide in the USA.

    Product
    AMIKACIN SULFATE — AMIKACIN SULFATE (AMIKACIN SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0250-2019·2018-11-21

    Kadesh Recalls Puriton Eye Relief Drops for Non-Sterility

    Kadesh International is recalling Puriton Eye Relief Drops because they were manufactured under non-sterile production conditions.

    Product
    puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0596-2018·2018-03-21

    Pfizer Recalls Hydromorphone Hydrochloride Injection Due to Non-Sterility Concerns

    Pfizer is recalling 53,600 vials of Hydromorphone Hydrochloride Injection due to confirmed customer complaints of empty or cracked glass vials.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0597-2018·2018-03-21

    Pfizer Recalls Hydromorphone Hydrochloride Injection Vials Due to Non-Sterility

    Pfizer is recalling 29,680 vials of Hydromorphone Hydrochloride Injection due to confirmed customer complaints of empty or cracked glass containers.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0551-2018·2018-03-07

    Kareway Recalls Gericare Eyewash Due to Confirmed Microbial Contamination

    Kareway Products Inc. is recalling 60,000 bottles of Gericare Eyewash because testing confirmed the presence of Achromobacter xylosoxidans bacteria.

    Product
    GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care Pharmaceuticals Corp., Brooklyn, NY 11204, NDC 57896-0186-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0600-2018·2018-02-21

    FDA Recalls Non-Sterile HCG and Methylcobalamin Injection Vials

    The Compounding Pharmacy of America is recalling 5 vials of HCG and Methylcobalamin injection due to non-sterility. The product was distributed in Tennessee and South Carolina.

    Product
    HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1177-2017·2017-10-04

    Pfizer Recalls Sterile Water for Injection Vials Due to Cracked Glass

    Pfizer is recalling 18,725 vials of Sterile Water for Injection due to cracked or chipped glass at the neck, which poses a non-sterility risk.

    Product
    Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentech, Inc., South San Francisco, CA 94080-4990. NDC 50242-901-24
    Category
    Drug
    Distribution
    Distributed nationwide