The Recall Desk

Hazard

Sterility Failure recalls

462 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 sterility failure 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.

401–425 of 462

  • HighFDA (Devices)·Z-0561-2022·2022-02-16

    Gentueri Viral Transport Medium Kit recalled due to sterility failure

    Gentueri Inc is recalling Viral Transport Medium Kits due to failed sterility testing and evidence of contamination. The recall affects 13,975 units distributed to Illinois, Nebraska, and Wisconsin.

    Product
    Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0413-2022·2022-02-02

    Phenol Injection Solution Recall Due to Lack of Sterility Assurance

    Edge Pharma, LLC is recalling Phenol Sterile Solution for Injection (6%, 5 mL vials) nationwide due to lack of assurance of sterility. The recall affects 309 vials distributed under specific lot codes.

    Product
    Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1476-05, packaged in vials.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0404-2022·2022-02-02

    Lidocaine HCL / Bupivacaine HCL Sterile Ophthalmic Solution Lacks Sterility Assurance

    Edge Pharma is recalling a sterile ophthalmic injectable solution because the manufacturer cannot guarantee that the product remains sterile. The recall affects approximately 1,202 syringes distributed nationwide.

    Product
    Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1548-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0414-2022·2022-02-02

    Eye Drops Recalled for Lack of Sterility Assurance by Edge Pharma

    Edge Pharma is recalling a multi-ingredient sterile ophthalmic solution nationwide due to lack of assured sterility. The product is used for topical eye application.

    Product
    Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1270-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0403-2022·2022-02-02

    Gemcitabine Intravesical Solution Recalled for Lack of Sterility Assurance

    Edge Pharma is recalling approximately 627 syringes of Gemcitabine Sterile Intravesical Solution nationwide because the manufacturer cannot guarantee the product is sterile. The recalled batches were distributed between December 2021 and February 2022.

    Product
    Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1566-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0369-2022·2022-01-19

    Exela Sodium Bicarbonate Injection Recalled for Sterility Assurance Failure

    Exela Pharma Sciences is recalling 8.4% Sodium Bicarbonate Injection due to lack of assurance of sterility. The affected lot (C0001088/P0001317, expiring 08/2023) was distributed nationwide.

    Product
    8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0302-2022·2022-01-05

    dilTIAZem HCl Injection Recalled Due to Sterility Assurance Failure

    SterRx is recalling dilTIAZem HCl 125 mg per 125 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects 24,300 bags distributed across the United States.

    Product
    dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0321-2022·2022-01-05

    SterRx Norepinephrine 8 mg Sodium Chloride Injection Recalled

    SterRx, LLC is recalling 74,508 bags of Norepinephrine 8 mg per 250 mL in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.

    Product
    NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-676-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0316-2022·2022-01-05

    SterRx Fentanyl Citrate Injection Recalled for Sterility Assurance Failure

    SterRx is recalling fentanyl citrate injection nationwide due to lack of assurance of sterility. The recall affects approximately 10,660 bags of the product.

    Product
    Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0304-2022·2022-01-05

    EPINEPHrine Injection Recall Due to Lack of Sterility Assurance

    SterRx is recalling EPINEPHrine 2 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects 2,779 bags distributed across the U.S.

    Product
    EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-027-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0313-2022·2022-01-05

    Morphine Sulfate Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling 40 bags of Morphine Sulfate in 5% Dextrose Injection (1 mg per mL) distributed nationwide due to lack of assurance of sterility. The product is subject to contamination risk.

    Product
    Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-452-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0319-2022·2022-01-05

    SterRx Norepinephrine Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling 1,044 bags of Norepinephrine 16 mg per 250 mL in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product carries NDC 70324-002-01 with lot code S21194/CDW.

    Product
    NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0301-2022·2022-01-05

    SterRx Morphine Sulfate Injection Recalled for Sterility Assurance

    SterRx is recalling Morphine Sulfate in 0.9% Sodium Chloride Injection (1 mg per mL) nationwide due to lack of assurance of sterility. The recall affects 880 units distributed across the United States.

    Product
    Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY, 12903, NDC 70324-427-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0324-2022·2022-01-05

    SterRx Phenylephrine HCl Injection Recalled for Sterility Assurance Failure

    SterRx is recalling phenylephrine HCl injectable solution nationwide due to lack of assurance of sterility. The affected product is a 50 mg per 250 mL injection in 0.9% sodium chloride.

    Product
    PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0260-2022·2021-12-08

    Methylcobalamin Solution for Injection Recalled for Sterility Risk

    ASP Cares is recalling Methylcobalamin Solution for Injection due to lack of assurance of sterility. The recall affects one lot distributed in the United States.

    Product
    Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only, Rx only, ASP Cares2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-565-30
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0262-2022·2021-12-08

    Ascorbic Acid Injection Recalled Due to Lack of Sterility Assurance

    ASP CARES is recalling Ascorbic Acid Solution for Injection (500 mg/mL, 50 mL vials) distributed in the United States because the manufacturer cannot assure the product meets sterility requirements.

    Product
    Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use Only, Rx only, ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-690-50
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0111-2022·2021-11-17

    Estradiol Valerate Injectable Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Estradiol Valerate 30 mg/mL Injectable due to lack of assurance of sterility. The product was distributed across the United States, Washington, D.C., and Puerto Rico.

    Product
    ESTRADIOL VALERATE 30MG/ML INJ #1 IN ETHYL OLEATE OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0218-2022·2021-11-17

    Compounded TRI-MIX Injectable Recalled for Lack of Sterility Assurance

    Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ injectable medication due to lack of assurance of sterility. The recall affects vials distributed across the United States, including Washington, D.C. and Puerto Rico.

    Product
    TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0128-2022·2021-11-17

    MIC/B Complex/Chrom/Carn/Lido Injectable Lacks Sterility Assurance

    Talon Compounding Pharmacy is recalling one lot of MIC/B Complex/Chrom/Carn/Lido Injectable (Lot 07292021:73, BUD 10/30/2021) distributed nationwide due to lack of assurance of sterility. Patients who received this injectable product should consult their healthcare provider.

    Product
    MIC 20/40/50 /B COMPLEX +CHROM/CARN 25/25MG/ML+LIDO 20/40/50/25/25MG/ML+LIDO INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0101-2022·2021-11-17

    Alprostadil Injectable Recall: Lack of Sterility Assurance

    Talon Compounding Pharmacy is recalling Alprostadil 25 mcg/mL injectable vials distributed across the United States due to lack of assurance of sterility, which could pose a health risk to patients.

    Product
    ALPROSTADIL 25MCG/ML 25MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0214-2022·2021-11-17

    TRI-MIX Injectable Compounded Drug Recalled for Sterility Assurance Failure

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 50 injectable medication due to lack of assurance of sterility. The recall affects vials distributed throughout the United States.

    Product
    TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 50 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0160-2022·2021-11-17

    Injectable Steroid Compound Recalled Due to Sterility Assurance Failure

    Talon Compounding Pharmacy is recalling a testosterone cypionate combination injectable product distributed nationwide due to lack of assurance of sterility, which could pose risk of serious infection.

    Product
    TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0174-2022·2021-11-17

    Testosterone Cypionate/Anastrozole Injectable Recalled for Lack of Sterility Assurance

    Vita Pharmacy (Talon Compounding Pharmacy) is recalling two lots of testosterone cypionate 200mg/anastrozole 0.7mg/ml injectable solution due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.7MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0185-2022·2021-11-17

    TRI-MIX Injectable by Talon Compounding Pharmacy Recalled for Sterility Assurance

    Talon Compounding Pharmacy is recalling TRI-MIX injectable medication because the manufacturer cannot assure that the product meets sterility requirements. Affected patients should consult their healthcare provider immediately.

    Product
    TRI-MIX PAPAV 23.3MG/PHENTOL 1MG/PGE-1 12MCG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0114-2022·2021-11-17

    Estradiol Valerate Injection Recall Due to Sterility Assurance Failure

    Talon Compounding Pharmacy is recalling Estradiol Valerate 50mg/ml Injectable (Lot 09162021:22) distributed across the United States because the manufacturer cannot assure the product's sterility.

    Product
    ESTRADIOL VALERATE 50MG/ML INJ #2 INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    0 states