The Recall Desk

Hazard

Sterility recalls

2,383 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,383
Critical
1
Severe
2,113
Most recent
2026-08-26

Of the 2,383 sterility recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,113 (89%) 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 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.

176–200 of 2383

  • SevereFDA (Drugs)·D-0744-2020·2020-01-22

    Assurance Infusion Recalls Hydromorphone Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of Hydromorphone 3mg/mL injection syringes due to a lack of sterility assurance. The products were distributed nationwide.

    Product
    HYDROMORPHONE 3MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0763-2020·2020-01-22

    Assurance Infusion Recalls QUADMIX Vials Due to Sterility Concerns

    Assurance Infusion is recalling QUADMIX in 1 mL vials because of a lack of sterility assurance. The affected lot was distributed nationwide.

    Product
    QUADMIX in 1 mL vial Assurance Infusion (713)-533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0703-2020·2020-01-22

    Assurance Infusion Recalls BUP 35MG/FENT 1.5MG/ML Syringes for Sterility Concerns

    Assurance Infusion is recalling BUP 35MG/FENT 1.5MG/ML in 20 mL syringes due to a lack of sterility assurance. The affected lot was distributed nationwide.

    Product
    BUP 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0777-2020·2020-01-22

    Assurance Infusion Recalls Trimix Forte 4 Injection Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of Trimix Forte 4 injection because the product may lack sterility assurance.

    Product
    TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0679-2020·2020-01-22

    Assurance Infusion Recalls BPC-157 Vials Due to Sterility Concerns

    Assurance Infusion is recalling BPC-157 vials nationwide because the product lacks sterility assurance.

    Product
    BPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0759-2020·2020-01-22

    Assurance Infusion Recalls Morphine Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of Morphine 5mg/mL injection syringes due to a lack of sterility assurance.

    Product
    MORPHINE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0734-2020·2020-01-22

    Assurance Infusion Recalls HCG Injection Vials Due to Sterility Concerns

    Assurance Infusion is recalling HCG 1,000U/1ML injection vials nationwide due to a lack of sterility assurance. Consumers should stop using the product and contact their healthcare provider.

    Product
    HCG 1,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0769-2020·2020-01-22

    Assurance Infusion Recalls Sufentanil Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of Sufentanil 55.5 mcg/mL injection syringes due to a lack of sterility assurance.

    Product
    SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0774-2020·2020-01-22

    Assurance Infusion Recalls TRIMIX Injection Due to Sterility Assurance Concerns

    Assurance Infusion is recalling specific lots of TRIMIX injection due to a lack of sterility assurance. The product was distributed nationwide in the United States.

    Product
    TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0749-2020·2020-01-22

    Assurance Infusion Recalls LIPO B Syringes and Vials for Sterility Concerns

    Assurance Infusion is recalling LIPO B 25MG/50MG/50MG/1000MCG/ML products due to a lack of sterility assurance. The recall covers nationwide distribution.

    Product
    LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0692-2020·2020-01-22

    Assurance Infusion Recalls BUP/CLON/FENT Injection Due to Sterility Concerns

    Assurance Infusion is recalling a specific lot of BUP 20MG/CLON 300MCG/FENT 2000MCG/ML Injection due to a lack of sterility assurance.

    Product
    BUP 20MG/CLON 300MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0687-2020·2020-01-22

    Assurance Infusion Recalls BUP 17MG/MORP 22MG/ML Injection Syringes

    Assurance Infusion is recalling BUP 17MG/MORP 22MG/ML injection syringes due to a lack of sterility assurance.

    Product
    BUP 17MG/MORP 22MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0743-2020·2020-01-22

    Assurance Infusion Recalls Hydromorphone Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of Hydromorphone 2mg/mL injection syringes because of a lack of sterility assurance.

    Product
    HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0664-2020·2020-01-22

    Assurance Infusion Recalls Multi-Drug Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of multi-drug injection syringes because of a lack of sterility assurance.

    Product
    BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. in 20 mL syringe Assurance Infusion (713)533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0731-2020·2020-01-22

    Assurance Infusion Recalls Fentanyl Syringes Due to Sterility Concerns

    Assurance Infusion is recalling Fentanyl 2000mcg/mL injection syringes because of a lack of sterility assurance. The recall covers products distributed nationwide.

    Product
    FENTANYL 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0397-2020·2019-11-27

    Altaire Recalls Ocusoft Goniosoft Ophthalmic Solution Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Ocusoft Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution due to a lack of assurance of sterility.

    Product
    Ocusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-503-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0366-2020·2019-11-27

    Altaire Recalls Equate Eye Gel Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Equate Comfort Gel Lubricant Eye Gel because the product lacks assurance of sterility.

    Product
    Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-197-49
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0432-2020·2019-11-27

    Altaire Nano Tears Lubricant Gel Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling Nano Tears TF Clear Emollient Lubricant Gel Drops due to a lack of assurance of sterility.

    Product
    Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct., Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-141-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0362-2020·2019-11-27

    Altaire Recalls Sodium Chloride Ophthalmic Solution Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling specific lots of Walgreens Sodium Chloride Ophthalmic Solution because the company cannot ensure the product is sterile.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide