The Recall Desk

Hazard

Sterility Assurance recalls

309 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 sterility assurance 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.

276–300 of 309

  • SevereFDA (Drugs)·D-0065-2022·2021-11-03

    MIT/B12 Compounded Injection Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling MIT/B12 25/50/50MG/ML 1MG/ML multidose vials due to FDA inspection findings that raised concerns about the lack of assurance of sterility. The product was distributed to approximately 494 patients across seven states.

    Product
    MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0063-2022·2021-11-03

    MIC/B12A Injectable Compounded Drug Recall for Sterility Assurance

    Red Mountain Compounding Pharmacy is recalling MIC/B12A 25/50/50MG/ML 1MG/ML MDV injectable medication because FDA inspection found the firm could not guarantee the sterility of the product. Approximately 494 patients across seven states received prescriptions for this medication.

    Product
    MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0033-2022·2021-11-03

    Ascorbic/Glutathione Eye Solution Recalled for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling an ascorbic/glutathione eye solution because FDA inspection identified concerns about sterility assurance during manufacturing.

    Product
    ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0031-2022·2021-11-03

    Ascorbic Acid Solution Recalled Due to Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling Ascorbic Acid (Non-Corn) 500mg/mL multi-dose solution due to FDA inspection findings regarding lack of sterility assurance. The affected product was distributed to approximately 494 patients across seven states.

    Product
    ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0053-2022·2021-11-03

    Acetylcysteine 10% ophthalmic solution recalled for sterility assurance concerns

    Red Mountain Compounding Pharmacy is recalling Acetylcysteine 10% ophthalmic solution due to lack of sterility assurance identified during an FDA inspection. Approximately 494 patients received prescriptions for the product across seven states.

    Product
    ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0044-2022·2021-11-03

    TEST CYP 200MG/ML injection recalled due to sterility assurance concerns

    Red Mountain Compounding Pharmacy is recalling TEST CYP 200MG/ML MDV ETHYL OLEATE due to FDA inspection findings of lack of assurance of sterility. The product was distributed to approximately 494 patients across seven states.

    Product
    TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0038-2022·2021-11-03

    Glutathione 200mg/mL MDV Recalled Due to Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling Glutathione 200mg/mL MDV (multiple-dose vials) because FDA inspection identified concerns that the product may lack proper sterility assurance. The product was distributed to patients in multiple states.

    Product
    GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0035-2022·2021-11-03

    Cyclosporine 2% MCT Oil Suspension Recalled for Sterility Assurance

    Red Mountain Compounding Pharmacy is recalling Cyclosporine 2% MCT Oil Suspension due to FDA inspection findings of sterility assurance concerns. Approximately 494 patients in seven states received prescriptions for this medication.

    Product
    CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0047-2022·2021-11-03

    TEST CYP/PROP Compounded Injection Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling TEST CYP/PROP 160/40MG/ML MDV in ethyl oleate due to FDA inspection findings that raised concerns about sterility assurance. Approximately 494 patients in multiple states received affected prescriptions.

    Product
    TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Drugs)·D-0055-2022·2021-11-03

    Benzalkonium Chloride Solution Recalled Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling Benzalkonium Chloride 0.013% Solution due to lack of assurance of sterility identified during an FDA inspection. Approximately 494 patients in seven states received prescriptions for this product.

    Product
    BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Drugs)·D-0043-2022·2021-11-03

    Testosterone Cypionate Injectable Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling testosterone cypionate 200mg/ml in sesame oil due to FDA concerns about lack of sterility assurance. The product was distributed to approximately 494 patients across seven states.

    Product
    TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Drugs)·D-0049-2022·2021-11-03

    Red Mountain Compounding Pharmacy Testosterone Blend Injection Sterility Recall

    Red Mountain Compounding Pharmacy is recalling a testosterone-blend injection product due to FDA concerns about sterility assurance. The product was distributed to patients in seven states.

    Product
    TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Drugs)·D-0056-2022·2021-11-03

    Calcium Gluconate 10% Injectable Recalled for Sterility Assurance

    Red Mountain Compounding Pharmacy is recalling Calcium Gluconate 10% Injectable (PF) due to lack of assurance of sterility following an FDA inspection. The product was distributed to approximately 494 patients across seven states.

    Product
    CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Drugs)·D-0050-2022·2021-11-03

    Testosterone Ultra 250MG/ML Recalled for Sterility Assurance Concerns

    First Royal Care Co. LLC, operating as Red Mountain Compounding Pharmacy, is recalling Testosterone Ultra 250MG/ML in sesame oil due to lack of assurance of sterility identified during FDA inspection.

    Product
    TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Drugs)·D-0036-2022·2021-11-03

    Dexpanthenol Injection Solution Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling Dexpanthenol 250mg/mL injection solution due to FDA findings that sterility assurance cannot be confirmed. The product was distributed to approximately 494 patients across seven states.

    Product
    DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Drugs)·D-0062-2022·2021-11-03

    MIC Compounded Injection Recalled Due to Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling MIC 25/50/50MG/ML MDV injectable medication due to lack of assurance of sterility following an FDA inspection. Approximately 494 patients in seven states received prescriptions for the affected product.

    Product
    MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Drugs)·D-0045-2022·2021-11-03

    TEST CYP 25MG/ML Injectable Lacks Assurance of Sterility

    Red Mountain Compounding Pharmacy is recalling TEST CYP 25MG/ML in Ethyl Oleate because FDA inspection raised concerns about sterility assurance. Approximately 494 patients in seven states received prescriptions for this drug.

    Product
    TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0067-2022·2021-11-03

    Sodium Selenite Injectable Solution Recalled for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling Sodium Selenite 200mcg/ml injectable solution due to FDA inspection findings regarding lack of assurance of sterility. Approximately 494 patients in seven states received prescriptions for this product.

    Product
    SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0064-2022·2021-11-03

    MIC/B12A/B6 Injection Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling MIC/B12A/B6 injectable medication because FDA inspection identified concerns about sterility assurance. The recall affects 494 patients across seven states.

    Product
    MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0034-2022·2021-11-03

    Cyclosporin 0.2% Oil Ophthalmic Suspension Recall Due to Sterility Assurance

    Red Mountain Compounding Pharmacy is recalling Cyclosporin 0.2% Oil Ophthalmic Suspension because FDA inspection identified concerns about sterility assurance. The recalled drug was distributed to approximately 494 patients across multiple states.

    Product
    CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0060-2022·2021-11-03

    Methylcobalamin injection recalled due to sterility assurance concerns

    Red Mountain Compounding Pharmacy is recalling a methylcobalamin injectable solution after FDA inspection raised concerns about the lack of assurance of sterility.

    Product
    METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0029-2022·2021-11-03

    Magnesium Chloride Injection Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling Magnesium Chloride 200 mg/mL injection because FDA inspection raised concerns about lack of assurance of sterility. The product was distributed to approximately 494 patients in seven states.

    Product
    Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Devices)·Z-0155-2022·2021-10-27

    medfusion Stopcock devices recalled due to sterility assurance deficiency

    Smiths Medical is recalling over 933,000 medfusion Stopcock medical devices internationally due to lack of sterility assurance. The devices may not meet required sterility standards.

    Product
    medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p. 888-10
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0007-2022·2021-10-20

    Potassium Chloride Injection Recall Due to Sterility Assurance Lack

    SSM Health Care St. Louis is recalling 385 bags of Potassium Chloride 40 mEq in 0.9% Sodium Chloride injection due to lack of assurance of sterility. The affected lot was distributed in Missouri.

    Product
    Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowles, Fenton, MO. NDC 60652-6429-1
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0856-2021·2021-10-06

    Morphine Sulfate Injection Recalled Due to Defective Vials

    Fresenius Kabi USA LLC is recalling 963,000 vials of Morphine Sulfate Injection because some vials are cracked, which compromises sterility assurance. The affected product was distributed nationwide.

    Product
    MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide