The Recall Desk

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.

26–50 of 447

  • HighFDA (Drugs)·D-0091-2026·2025-10-15

    Semaglutide for Injection Recalled for Lack of Sterility Assurance

    GenoGenix LLC is recalling specific lots of Semaglutide for Injection due to inability to assure product sterility. The product was distributed nationwide.

    Product
    Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0075-2026·2025-10-15

    Elite Stack Reconstitution Solution for Injection Recalled for Sterility Assurance

    GenoGenix LLC is recalling Elite Stack Reconstitution Solution for Injection nationwide due to lack of assured sterility. All unexpired lots are included in the Class II recall.

    Product
    Elite Stack Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Medical Health Institute (MHI).
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0084-2026·2025-10-15

    Zinc Chloride for Injection Recalled Nationwide Due to Sterility Concerns

    GenoGenix LLC is recalling all lots of Zinc Chloride for Injection nationwide due to lack of assurance of sterility. No illnesses or injuries have been reported.

    Product
    Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0041-2026·2025-10-15

    Ascorbic Acid Injection Recalled Due to Sterility Assurance Failure

    GenoGenix LLC is recalling all lots of Ascorbic Acid (Vitamin C) for Injection due to lack of assurance of sterility. The recall affects approximately 1,550 units distributed nationwide.

    Product
    Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0064-2026·2025-10-15

    Injectable N-Acetyl-L-Cysteine Recalled Due to Sterility Assurance Failure

    GenoGenix, LLC is recalling all lots of N-Acetyl-L-Cysteine for Injection due to lack of assurance of sterility. All strengths and presentations distributed nationwide in the U.S. are affected.

    Product
    N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0039-2026·2025-10-15

    Amino Blend for Injection Recalled Due to Lack of Sterility Assurance

    GenoGenix is recalling all lots of Amino Blend for Injection nationwide due to lack of assurance of sterility. Patients should consult their healthcare provider.

    Product
    Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0044-2026·2025-10-15

    B5 Dexpanthenol for Injection Recalled Due to Sterility Assurance Concerns

    GenoGenix LLC is recalling B5 Dexpanthenol for Injection due to lack of assurance of sterility. The recall affects all lots within expiry distributed nationwide.

    Product
    B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0090-2026·2025-10-15

    Sermorelin Injectable Powder Recalled for Sterility Assurance Issues

    GenoGenix LLC is recalling a specific lot of Sermorelin injectable powder due to lack of assurance of sterility. The affected lot (GG062425-002) was distributed nationwide.

    Product
    Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0087-2026·2025-10-15

    Thymosin Beta-4 Injectable Recalled for Lack of Sterility Assurance

    GenoGenix's Thymosin Beta-4 15mg injectable is recalled due to lack of assurance of sterility. Lot GG060525-001 has been distributed nationwide; patients should consult their healthcare provider.

    Product
    Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0058-2026·2025-10-15

    L-Glutamine for Injection Recalled Due to Lack of Sterility Assurance

    GenoGenix LLC is recalling all lots of L-Glutamine for Injection nationwide because the company cannot assure the product meets sterility requirements for safe injection.

    Product
    L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0086-2026·2025-10-15

    Injection Products Recalled for Lack of Sterility Assurance by GenoGenix

    BPC-157/Thymosin Beta-4 injections from GenoGenix are being recalled due to lack of assurance of sterility. The recall affects products distributed nationwide.

    Product
    BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute (MHI).
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0043-2026·2025-10-15

    B12 Methylcobalamin Injectable Recalled Due to Lack of Sterility Assurance

    GenoGenix LLC is recalling all strengths of B12 Methylcobalamin for Injection nationwide due to lack of assurance of sterility. All lots within expiry are affected.

    Product
    B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as, manufactured for Synergy Wellness.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0092-2026·2025-10-15

    Tirzepatide Injectable Solution Recalled for Lack of Sterility Assurance

    GenoGenix has recalled Tirzepatide 60mg/10mL injectable vials nationwide due to lack of assurance of sterility. The affected lots are GG012925-005 and GG021125-003.

    Product
    Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0051-2026·2025-10-15

    GHK-Cu Injectable Medication Recalled Due to Sterility Assurance Failure

    GenoGenix is recalling all lots of GHK-Cu (Copper Peptide) for Injection nationwide due to lack of assurance of sterility. The 221 units affected were distributed across the US.

    Product
    GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0070-2026·2025-10-15

    Zinc Sulfate for Injection Recalled Nationwide Due to Sterility Concerns

    GenoGenix LLC is recalling all lots of Zinc Sulfate for Injection due to lack of assurance of sterility. The affected products were distributed nationwide and may pose infection risk to patients.

    Product
    Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0056-2026·2025-10-15

    L-Arginine HCl for Injection Recalled for Lack of Sterility Assurance

    GenoGenix LLC is recalling L-Arginine HCl for Injection due to lack of sterility assurance. The recall affects all strengths and presentations distributed nationwide.

    Product
    L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0677-2025·2025-10-08

    Ketorolac Ophthalmic Solution Recalled for Sterility Concerns Due to Improper Bottle Sealing

    Apotex Corp. is recalling approximately 493,468 bottles of Ketorolac Tromethamine Ophthalmic Solution nationwide due to lack of sterility assurance from improper bottle sealing. The defect may allow contamination of the eye medication.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0652-2025·2025-09-24

    Sterile Water for Injection bags recalled for sterility and leakage risk

    B. Braun is recalling Sterile Water for Injection (3000mL) due to potential fluid leakage from port misalignment. This could compromise sterility and create contamination risk for IV patients.

    Product
    STERILE WATER — STERILE WATER (WATER)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0589-2025·2025-08-27

    BZK Antiseptic Towelettes Recalled for Lack of Sterility Assurance

    Taizhou Kangping Medical is recalling 3.85 million cartons of BZK Antiseptic Towelettes due to lack of assurance of sterility. The product is intended for external wound care by healthcare professionals.

    Product
    BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu, China, NDC: 71310-111-01
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0500-2025·2025-07-09

    Ketamine Injection Recalled Due to Sterility Assurance Concerns

    Tailstorm Health is recalling Ketamine Hydrochloride Injection due to manufacturing process concerns that could affect product sterility. The recall involves 23,200 vials distributed nationwide.

    Product
    KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0475-2025·2025-07-02

    CJC-1295 Injectable Syringes Recalled for Lack of Sterility Assurance

    Thrive Health Solutions is recalling 60 syringes of CJC-1295 Injectable due to lack of assurance of sterility. Non-sterile injectables pose a risk of infection to patients.

    Product
    CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0480-2025·2025-07-02

    Semaglutide injectable syringes recalled nationwide due to sterility assurance concerns

    Thrive Health Solutions is recalling 164 pre-filled syringes of Semaglutide 5 mg/mL due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0479-2025·2025-07-02

    Semaglutide Pre-filled Syringes Recalled for Sterility Assurance Issues

    Thrive Health Solutions is recalling Semaglutide 2.5 mg/mL pre-filled syringes nationwide for lack of assurance of sterility. Patients with affected syringes should contact their healthcare provider.

    Product
    Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0484-2025·2025-07-02

    Tirzepatide Injections Recalled Due to Lack of Sterility Assurance

    Thrive Health Solutions is recalling Tirzepatide Injections due to lack of assurance of sterility. Lot H388348 was distributed nationwide in the United States.

    Product
    Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
    Category
    Drug
    Distribution
    Distributed nationwide