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.

426–450 of 1417

  • SevereFDA (Drugs)·D-0693-2021·2021-07-28

    Compounded Lyophilized AOD-9604 Injection Recalled for Sterility Risk

    Innoveix Pharmaceuticals is recalling compounded lyophilized AOD-9604 3 mg injection vials nationwide due to lack of assurance of sterility. The affected product was distributed as Rx-only injectable medication.

    Product
    Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0216-2021·2021-01-13

    SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,152 single-dose syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.

    Product
    PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0207-2021·2021-01-13

    SCA Pharmaceuticals Recalls Sodium Citrate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 5,990 syringes of Sodium Citrate 4% Anticoagulation Solution due to a lack of assurance of sterility and potential defective caps.

    Product
    Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2126-2020·2020-06-03

    Thermo Fisher Recalls Non-Sterile Bio-Tite Specimen Containers

    Thermo Fisher Scientific is recalling 78,600 Bio-Tite specimen containers that were not irradiated and are not sterile.

    Product
    Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1093-2020·2020-04-15

    PharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Issues

    PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products because of a lack of sterility assurance.

    Product
    fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1099-2020·2020-04-15

    Innovative Compounding Pharmacy Recalls Alprostadil Injection Due to Sterility Concerns

    Innovative Compounding Pharmacy is recalling Alprostadil, Papaverine, and Phentolamine injection due to a lack of assurance of sterility. The product was distributed to patients in California, Maine, and Texas.

    Product
    Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1088-2020·2020-04-15

    PharMEDium Recalls ePHEDrine Sulfate IV Syringes Due to Sterility Concerns

    PharMEDium Services is recalling 375 units of ePHEDrine Sulfate IV syringes because of a lack of sterility assurance.

    Product
    ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1084-2020·2020-04-15

    PharMEDium Recalls Hydromorphone Syringes Due to Sterility Assurance Issues

    PharMEDium Services is recalling 46 lots of Hydromorphone in 0.9% Sodium Chloride HCl syringes due to a lack of sterility assurance.

    Product
    HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1091-2020·2020-04-15

    PharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues

    PharMEDium Services is recalling 46 lots of ePHEDrine Sulfate syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1076-2020·2020-04-08

    Medical Center Pharmacy Recalls Gentamicin Bladder Irrigation Bags

    Medical Center Pharmacy is recalling 250 mL bags of Gentamicin/Bacitracin Bladder Irrigation due to concerns that production processes cannot assure sterility.

    Product
    C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 63323-0010-02.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0951-2020·2020-03-11

    Axia Pharmaceutical Recalls Dexamethasone Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling Dexamethasone (LA) Injectable Suspension because the product lacks assurance of sterility. The recall covers specific lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0630-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0948-2020·2020-03-11

    Axia Pharmaceutical Recalls Cyanocobalamin Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Cyanocobalamin Injection because the product lacks assurance of sterility.

    Product
    Cyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0330-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0938-2020·2020-03-11

    Axia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Alprostadil/Papaverine/Phentolamine Injection due to a lack of assurance of sterility. The product was distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/30MG/2MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0546-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0946-2020·2020-03-11

    Axia Pharmaceutical Recalls Calcium Chloride Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Calcium Chloride Injection due to a lack of assurance of sterility. The affected product was distributed nationwide and in several international locations.

    Product
    Calcium Chloride Injection, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0953-2020·2020-03-11

    Axia Pharmaceutical Recalls Glutathione Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Glutathione Injection because the product lacks assurance of sterility. The recall covers distribution in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1231-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0940-2020·2020-03-11

    Axia Pharmaceutical Recalls AscorbiX Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling AscorbiX (Buffered C) Injection because the product lacks assurance of sterility. The recall covers specific lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0226-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0942-2020·2020-03-11

    Axia Pharmaceutical Recalls Betamethasone Injectable Suspension Due to Sterility Concerns

    Fusion IV Pharmaceuticals is recalling specific lots of Betamethasone Injectable Suspension because the company cannot guarantee the product is sterile.

    Product
    BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [2ML] 6MG/ML INJ SUSP, For IM, IA, IT Use, Shake Well. Preservative Free. Discard Unused Portion, 2 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. St
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0981-2020·2020-03-11

    Axia Pharmaceutical Recalls Selenium Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Selenium Injection because the product lacks assurance of sterility.

    Product
    Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0227-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0972-2020·2020-03-11

    Axia Pharmaceutical Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Methylprednisolone Acetate Injectable Suspension because the company cannot guarantee the product is sterile.

    Product
    Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 50 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0636-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0778-2020·2020-01-22

    Assurance Infusion Recalls Trimix Forte Plus Injection Vials for Sterility Concerns

    Assurance Infusion is recalling 20 vials of Trimix Forte Plus injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0682-2020·2020-01-22

    Assurance Infusion Recalls BUP 10MG/HYDROM 15MG/SUF 200MCG/ML Injection Syringes

    Assurance Infusion is recalling specific lots of BUP 10MG/HYDROM 15MG/SUF 200MCG/ML Injection syringes due to a lack of sterility assurance.

    Product
    BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0688-2020·2020-01-22

    Assurance Infusion Recalls BUP 1MG//ML/HYDROM 7MG Injection Due to Sterility Concerns

    Assurance Infusion is recalling BUP 1MG//ML/HYDROM 7MG Injection in 20 mL syringes due to a lack of sterility assurance. The recall covers nationwide distribution in the United States.

    Product
    BUP 1MG//ML/HYDROM 7MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0770-2020·2020-01-22

    Assurance Infusion Recalls Testosterone Cypionate Oil Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of Testosterone Cypionate 200mg/mL oil due to a lack of sterility assurance. The affected vials were distributed nationwide.

    Product
    TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0733-2020·2020-01-22

    Assurance Infusion Recalls Fentanyl Injection Due to Sterility Concerns

    Assurance Infusion is recalling Fentanyl 800mcg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide in the United States.

    Product
    FENTANYL 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide