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.

576–600 of 2383

  • SevereFDA (Drugs)·D-0468-2019·2019-02-20

    Promise Pharmacy Recalls Nicotinamide Adenine Dinucleotide Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling specific lots of Nicotinamide Adenine Dinucleotide injections due to a lack of sterility assurance. The affected products were distributed nationwide in the USA.

    Product
    Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0352-2019·2019-01-16

    Heritage Pharmaceuticals Recalls Cidofovir Injection Due to Sterility Concerns

    Heritage Pharmaceuticals is recalling Cidofovir Injection vials due to complaints about dried powder on the outside of the bottles, which raises concerns about sterility.

    Product
    Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0233-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Assurance Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 200mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 count (NDC 69761-120-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0237-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 87.5mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69761-187-12), and 30 count (NDC 69761-187-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0238-2019·2018-11-14

    Qualgen Testosterone and Anastrozole Pellets Recalled for Sterility Concerns

    Qualgen, LLC is recalling Testosterone 200 mg/Anastrozole 20 mg pellets due to a lack of assurance of sterility. The recall affects specific vial sizes distributed nationwide.

    Product
    Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69761-222-06), 12 count (NDC 69761-222-12), and 30 count (NDC 69761-222-30) vials, Rx Only, Qualgen, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0215-2019·2018-11-14

    ICU Medical Recalls 5% Dextrose Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 5% Dextrose Injection bags because they may lack sterility and have the potential to leak.

    Product
    5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0225-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Qualgen, LLC is recalling Estradiol 10mg pellets nationwide due to a lack of assurance of sterility. The affected lots have specific expiration dates.

    Product
    Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count (NDC 69761-010-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0226-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Sterility Assurance Concerns

    Qualgen, LLC is recalling Estradiol 12.5mg pellets nationwide because the company cannot ensure the product is sterile.

    Product
    Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0235-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 37.5 mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 69761-137-12) and 30 count (NDC 69761-137-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0224-2019·2018-11-14

    Avella Recalls Bevacizumab Syringes Due to Sterility Assurance Concerns

    Avella of Deer Valley is recalling 911 pre-filled Bevacizumab syringes due to a lack of assurance of sterility. The product was distributed throughout the United States.

    Product
    BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) Repackaged by Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix, AZ 85085. NDC 42852-001-24
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0236-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 50mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 count (NDC 69761-150-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0191-2019·2018-11-07

    Pharm D Solutions Recalls Tri-Mix Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling 609 vials of Tri-Mix Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC 69699-1332-05 b) (LYO) Powder NDC 69699-1332-05, Pharm D Solutions, Houston, Texas
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0172-2019·2018-11-07

    Pharm D Solutions Recalls Phosphate Buffer Solution Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Phosphate Buffer Solution 0.05 m Aqueous Solution because the company cannot assure the product's sterility.

    Product
    Phosphate Buffer Solution 0.05 m Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-0912-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0133-2019·2018-11-07

    Avella Recalls Hydromorphone Bags Due to Sterility Assurance Concerns

    Avella of Deer Valley, Inc. is recalling 360 bags of Hydromorphone in NS due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0138-2019·2018-11-07

    Pharm D Solutions Recalls Ascorbic Acid Solution Due to Sterility Concerns

    Pharm D Solutions is recalling Ascorbic Acid 500 mg/mL Solution due to a lack of assurance of sterility. The recall affects nationwide distribution.

    Product
    Ascorbic Acid 500 mg/mL Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1502-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0206-2019·2018-11-07

    Pharm D Solutions Recalls Trimix Aqueous Solution Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Trimix aqueous solution because the agency could not ensure the product was sterile.

    Product
    Trimix ST9D 30PA-2PH-150A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1311-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0195-2019·2018-11-07

    Pharm D Solutions Recalls Trimix T 101 Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Trimix T 101 Injectable due to a lack of assurance of sterility. The recall covers a specific lot distributed nationwide.

    Product
    Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65 mg/0.59 mcg per mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1336-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0137-2019·2018-11-07

    Pharm D Solutions Recalls Arginine Injections Due to Sterility Concerns

    Pharm D Solutions is recalling Arginine Injections 100 mcg/mL due to a lack of assurance of sterility. The affected lots were distributed nationwide.

    Product
    Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0177-2019·2018-11-07

    Pharm D Solutions Recalls Atropine Solution Due to Sterility Concerns

    Pharm D Solutions is recalling QM-4A Quadmix Atropine 0.4 mg Aqueous Solution because there is a lack of assurance of sterility.

    Product
    QM-4A Quadmix 5 mL 30 PA-2PH-150A-Atropine 0.4 mg Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1342-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0160-2019·2018-11-07

    Pharm D Solutions Recalls HCG Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling 881 vials of HCG Lyopholized 1200 IU Injectable nationwide due to a lack of assurance of sterility.

    Product
    HCG Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1743-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0207-2019·2018-11-07

    Pharm D Solutions Recalls Trimix T-101 Injection Due to Sterility Concerns

    Pharm D Solutions is recalling Trimix T-101 injection because the product may lack assurance of sterility.

    Product
    Trimix T-101 Alprostadil/Phapaverine/Phentolamine 5.9 mcg/17.65 mg/Phentolamine 0.59 mcg per mL Pharm D Solutions, Houston, Texas --- NDC 69699-1366-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0152-2019·2018-11-07

    Pharm D Solutions Recalls Epinephrine Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling 945 syringes of Epinephrine 1 mg/1 mL injectable solution nationwide due to a lack of assurance of sterility.

    Product
    Epinepherine 1 mg/1 mL 3 mL Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-0109-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0197-2019·2018-11-07

    Pharm D Solutions Recalls Trimix Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Trimix Injectable because the agency could not ensure the product was sterile.

    Product
    Trimix Alprostadil/ Phentolamine/Papavarin 40 mcg/1 mg/30 mg 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1330-05
    Category
    Drug
    Distribution
    Distributed nationwide