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.

351–375 of 1417

  • SevereFDA (Drugs)·D-0656-2022·2022-03-23

    Hydromorphone HCl Infusion Bags Recalled for Lack of Sterility Assurance

    Family Pharmacy of Statesville is recalling Hydromorphone HCl 2 mg/mL Infusion 250 mL bags (2 units) distributed in North Carolina due to lack of assurance of sterility.

    Product
    Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0660-2022·2022-03-23

    Trimix Injectable Vials Recalled for Lack of Sterility Assurance

    Family Pharmacy of Statesville is recalling Trimix injectable vials (Alprostadil/Papaverine/Phentolamine 20 mcg/30 mg/0.5 mg) due to lack of assurance of sterility. The recall affects 2 vials distributed in North Carolina.

    Product
    Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0412-2022·2022-02-02

    MVASI Sterile Ophthalmic Solution Lacks Assured Sterility

    Edge Pharma is recalling MVASI (bevacizumab-awwb) intraocular injection syringes nationwide due to lack of assurance of sterility. The recall affects 199 syringes with code 11-2021-01@2 dated 12/15/2021.

    Product
    MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.13 mL per syringe, Dose: 1.25mg/0.05mL, Single Use Syringe For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1661-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0399-2022·2022-02-02

    Dexamethasone Sodium Phosphate Otic Injection Syringes Recalled for Lack of Sterility Assurance

    Edge Pharma LLC is recalling Dexamethasone sodium phosphate sterile otic solution for injection syringes (NDC 05446-0848-01) due to lack of assurance of sterility. Approximately 323 syringes were distributed nationwide.

    Product
    Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe For Otic Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0848-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0394-2022·2022-02-02

    ALUM Concentrate IV Bags Recalled for Lack of Sterility Assurance

    Edge Pharma, LLC is recalling ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate) IV bags nationwide due to lack of assurance of sterility. The affected product is a prescription intravenous medication supplied in 300 ml bags.

    Product
    ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0427-2022·2022-02-02

    Vancomycin HCl IV Injection Recalled Due to Sterility Assurance Concerns

    Edge Pharma is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The recall affects approximately 749 bags distributed nationwide.

    Product
    Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446 NDC 05446-1459-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0424-2022·2022-02-02

    Vancomycin HCl Ophthalmic Solution Recalled for Sterility Assurance

    Edge Pharma LLC is recalling Vancomycin HCl sterile ophthalmic solution for injection due to lack of assurance of sterility. The affected product was distributed nationwide.

    Product
    Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0736-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0407-2022·2022-02-02

    Mitomycin-C Injectable Syringes Recalled for Sterility Assurance Failure

    Edge Pharma is recalling Mitomycin-C 40 mg/40 mL single-dose syringes (NDC 05446-1416-01) nationwide due to lack of assurance of sterility. Approximately 860 syringes are affected.

    Product
    Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0402-2022·2022-02-02

    Epinephrine/Lidocaine Ophthalmic Injection Syringe Recall for Sterility Assurance

    Edge Pharma is recalling Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection due to lack of assurance of sterility. The recall affects 2,568 single-use syringes distributed nationwide.

    Product
    Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0406-2022·2022-02-02

    Methotrexate Injection Recalled Due to Lack of Sterility Assurance

    Edge Pharma, LLC is recalling Methotrexate, USP, Sterile Solution for Injection (125 mg/5mL) due to lack of assurance of sterility. The recall affects 457 syringes distributed nationwide.

    Product
    Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1505-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0370-2022·2022-01-19

    Methylprednisolone Acetate Injectable Suspension Lacks Sterility Assurance

    Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension 400 mg/10mL due to lack of assurance of sterility. The recall affects one lot distributed to facilities in Tennessee, Mississippi, and Ohio.

    Product
    MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0323-2022·2022-01-05

    SterRx Phenylephrine HCl Injection Recalled for Sterility Assurance

    SterRx is recalling PHENYLephrine HCl 40 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects approximately 20,640 bags distributed across the United States.

    Product
    PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0306-2022·2022-01-05

    Sodium Bicarbonate in 5% Dextrose Injection Recalled for Sterility Assurance

    SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The recall affects 127,260 bags distributed across the U.S.

    Product
    Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0310-2022·2022-01-05

    Epinephrine Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling epinephrine injection (8 mg per 250 mL) due to lack of assurance of sterility. The recall affects 5,832 bags distributed nationwide.

    Product
    EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-077-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0309-2022·2022-01-05

    Epinephrine Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling epinephrine in 0.9% sodium chloride injection (5 mg per 250 mL) nationwide due to lack of assurance of sterility. Affected lots are identified by codes S21255/BXA, S21264/BXH, and S21328/BZO.

    Product
    EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-052-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0315-2022·2022-01-05

    dilTIAZem HCl in Dextrose Injection Recalled for Sterility Assurance

    SterRx is recalling dilTIAZem HCl in 5% Dextrose Injection due to lack of assurance of sterility. The recall affects 8,946 bags distributed nationwide.

    Product
    dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0311-2022·2022-01-05

    SterRx Epinephrine Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling 684 bags of epinephrine in 0.9% sodium chloride injection nationwide due to lack of assurance of sterility. The product is supplied to hospitals and healthcare facilities.

    Product
    EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0312-2022·2022-01-05

    Midazolam Injection Recalled Due to Lack of Sterility Assurance

    SterRx is recalling Midazolam in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The recall affects approximately 36,360 bags distributed across the United States.

    Product
    Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-102-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0300-2022·2022-01-05

    SterRx Midazolam Injection Recalled for Lack of Sterility Assurance

    SterRx, LLC is recalling Midazolam in 0.9% Sodium Chloride Injection (50 mg per 50 mL) distributed nationwide due to lack of assurance of sterility. The recall affects 15,660 bags from seven lots manufactured between November and December 2021.

    Product
    Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #70324-102-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0322-2022·2022-01-05

    Norepinephrine Injection Recalled Due to Lack of Sterility Assurance

    SterRx is recalling 36,576 bags of Norepinephrine 16 mg per 250 mL injection (0.9% Sodium Chloride) distributed nationwide because the manufacturer cannot assure the product meets sterility requirements.

    Product
    NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-926-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0261-2022·2021-12-08

    Biotin Solution for Injection recalled due to lack of sterility assurance

    ASP CARES is recalling Biotin Solution for Injection (10 mg/mL, 30 mL vials) because the manufacturer cannot assure the product's sterility. The affected lot was distributed in the United States.

    Product
    Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-0589-30
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0108-2022·2021-11-17

    Compounded Injectable Injection Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Blue Tree Lipo Extreme injectable (with Methylcobalamin) due to lack of assurance of sterility. The product was distributed in the United States.

    Product
    BLUE TREE LIPO EXTREME (/W METHYLCOBALAMIN) INJECTION INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0219-2022·2021-11-17

    TRI-MIX Papaverine Injectable Recalled for Sterility Assurance Failure

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 injectable medication due to lack of assurance of sterility.

    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
    2 states
  • SevereFDA (Drugs)·D-0184-2022·2021-11-17

    Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 50mg/mL injectable vials because the manufacturer cannot assure that the product is sterile. The affected product was distributed across the United States, including Washington, D.C. and Puerto Rico.

    Product
    TESTOSTERONE CYPIONATE 50MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0136-2022·2021-11-17

    Quad-Mix Injectable Compound Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a compounded injectable medication (Quad-Mix Papav 30/Phentol 1/PGE-1 10/Atropine 0.15) due to lack of assurance of sterility. The affected lot was distributed across the United States, Washington D.C., and Puerto Rico.

    Product
    QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 10/ATROPINE 0.15 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states