The Recall Desk

Hazard

Lack Of Sterility recalls

1,423 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,423
Critical
3
Severe
1,055
Most recent
2026-10-14

Of the 1,423 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 1,055 (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.

826–850 of 1423

  • SevereFDA (Drugs)·D-0395-2019·2019-01-09

    Northwest Compounding Pharmacy Recalls HCG Liquid Due to Sterility Concerns

    Northwest Compounding Pharmacy is recalling HCG liquid vials because they may lack sterility assurance. The product was distributed in Oregon to medical facilities and patients.

    Product
    HCG liquid, 1000u/ml, RX, glass vial, various
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0398-2019·2019-01-09

    Northwest Compounding Pharmacy Recalls Lidocaine/Epinephrine Liquid Due to Sterility Concerns

    Northwest Compounding Pharmacy is recalling Lidocaine/Epinephrine liquid 1%/1:1000 in 50 ml glass vials due to a lack of sterility assurance. The product was distributed in Oregon to medical facilities and patients.

    Product
    Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0404-2019·2019-01-09

    Northwest Compounding Pharmacy Recalls Cyclosporin Liquid Due to Sterility Concerns

    Northwest Compounding Pharmacy is recalling compounded Cyclosporin liquid 0.5% in plastic dropper bottles due to a lack of sterility assurance. The product was distributed in Oregon to medical facilities, a physician's office, and patients.

    Product
    Cyclosporin liquid 0.5%, Rx, plastic dropper bottle
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0227-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Qualgen, LLC is recalling Estradiol 15mg pellets because the company cannot ensure the products are sterile. The recall covers specific lots distributed nationwide.

    Product
    Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0230-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Qualgen, LLC is recalling Estradiol 6 mg pellets nationwide because the company cannot ensure the product is sterile.

    Product
    Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count (NDC 69761-006-12), and 30 count (NDC 69761-006-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0229-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Qualgen, LLC is recalling Estradiol 25mg pellets because the company cannot assure the sterility of the product. The recall covers specific lots distributed nationwide.

    Product
    Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count (NDC 69761-025-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0234-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 25 mg pellets nationwide because the company lacks assurance of sterility for these products.

    Product
    Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0179-2019·2018-11-07

    Pharm D Solutions Recalls Sermorelin/Ipamorelin Powder Due to Sterility Concerns

    Pharm D Solutions is recalling 179 vials of Sermorelin/Ipamorelin powder because the company cannot ensure the product is sterile.

    Product
    Sermorelin/Ipamorelin 18 mg/15 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1759-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0208-2019·2018-11-07

    Pharm D Solutions Recalls Trimix T-106 Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Trimix T-106 aqueous solution because the company cannot ensure the product is sterile.

    Product
    Trimix T-106 30PA-1PH-25A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1339-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0201-2019·2018-11-07

    Pharm D Solutions Recalls Trimix Injection Due to Sterility Concerns

    Pharm D Solutions is recalling 430 vials of Trimix injection because the company cannot guarantee the product is sterile.

    Product
    Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1367-02
    Category
    Drug
    Distribution
    Distributed nationwide