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.

326–350 of 447

  • HighFDA (Drugs)·D-1210-2022·2022-07-20

    Compounded injectable product recalled for lack of sterility assurance

    Tailor Made Compounding is recalling 25 vials of a compounded injectable product due to lack of assurance of sterility. The affected batches were distributed nationwide.

    Product
    Inositol/Choline B12 + Carnitine 40mg/40mg/1mg/100mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1225-2022·2022-07-20

    Compounded Semaglutide/Cyanocobalamin Vials Recalled Over Sterility Concerns

    Tailor Made Compounding recalled 9,993 vials of compounded semaglutide/cyanocobalamin due to lack of assurance of sterility. No illnesses have been reported.

    Product
    Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1221-2022·2022-07-20

    Injectable Drug Pentosan Polysulfate Sodium Recalled for Sterility Assurance

    Tailor Made Compounding is recalling 220 vials of Pentosan Polysulfate Sodium due to lack of assurance of sterility. The affected batches were distributed nationwide in the United States and Puerto Rico.

    Product
    Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1208-2022·2022-07-20

    Hydroxocobalamin Compounded Injections Recalled for Lack of Sterility Assurance

    Tailor Made Compounding is recalling 63 vials of Hydroxocobalamin 25mg/mL injectable solution nationwide due to lack of assurance of sterility. Consumers should not use affected batches.

    Product
    Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1228-2022·2022-07-20

    Sermorelin/Glycine Injectable Recalled for Lack of Sterility Assurance

    A compounded sermorelin/glycine injectable has been recalled because the manufacturer cannot assure the product is sterile. The recall affects approximately 2,870 vials distributed nationwide.

    Product
    Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1197-2022·2022-07-20

    Biotin 5mg/mL injection recalled for lack of sterility assurance

    Tailor Made Compounding is recalling Biotin 5mg/mL injections distributed nationwide and in Puerto Rico because the manufacturer cannot assure the products were sterilized according to FDA standards.

    Product
    Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1241-2022·2022-07-20

    Vitamin B-Complex Injectable Vials Recalled for Lack of Sterility Assurance

    Tailor Made Compounding is recalling Vitamin B-Complex Preservative Free injectable vials (batch 03112233B) nationwide due to lack of assurance of sterility. The product should not be used.

    Product
    Vitamin B-Complex Preservative Free, 3ml-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1240-2022·2022-07-20

    Vitamin B-Complex Injectable Vials Recalled for Lack of Sterility

    Tailor Made Compounding is recalling Vitamin B-Complex injectable vials (10 mL and 30 mL) distributed nationwide USA and Puerto Rico due to lack of assurance of sterility.

    Product
    Vitamin B-Complex, a) 10 mL-vial, b) 30 mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1217-2022·2022-07-20

    Methylcobalamin Injectable Recalled Due to Lack of Sterility Assurance

    Tailor Made Compounding is recalling Methylcobalamin Preservative Free 10mg/mL injectable due to lack of assurance of sterility. The affected batch may not meet sterility standards required for injectable medications.

    Product
    Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1235-2022·2022-07-20

    Testosterone Injections Recalled for Lack of Sterility Assurance

    Tailor Made Compounding is recalling 246 vials of compounded testosterone injections distributed nationwide due to lack of assurance of sterility. Non-sterile injectable medications may pose a risk of infection.

    Product
    Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 ml-vial, Room temperature, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1199-2022·2022-07-20

    Dexpanthenol injectable vials recalled for lack of sterility assurance

    Tailor Made Compounding is recalling 19 vials of Dexpanthenol 250mg/mL due to lack of assurance of sterility. Two batches with different expiration dates were distributed nationwide in the USA and Puerto Rico.

    Product
    Dexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1224-2022·2022-07-20

    Semaglutide/Cyanocobalamin Injectable Recalled for Lack of Sterility Assurance

    Tailor Made Compounding is recalling 5,842 vials of compounded semaglutide/cyanocobalamin injectable due to lack of sterility assurance. The product was distributed nationwide in the United States and Puerto Rico.

    Product
    Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1206-2022·2022-07-20

    Tailor Made Compounding Recalls Glycyrrhizic Acid Injectable for Lack of Sterility Assurance

    Tailor Made Compounding recalls 101 vials of Glycyrrhizic Acid (8mg/mL) nationwide due to lack of assurance of sterility in this injectable preparation. Patients should contact their healthcare provider.

    Product
    Glycyrrhizic Acid 8mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1216-2022·2022-07-20

    Methylcobalamin 1mg/mL Vials Recalled for Lack of Sterility Assurance

    TMC Acquisition LLC recalls 191 vials of Methylcobalamin 1mg/mL distributed nationwide and in Puerto Rico due to lack of sterility assurance. Consult your healthcare provider regarding any vials in your possession.

    Product
    Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1226-2022·2022-07-20

    Sermorelin Recalled Due to Lack of Sterility Assurance

    Tailor Made Compounding is recalling 1,208 vials of Sermorelin due to inability to assure sterility. The product was distributed nationwide in the USA and Puerto Rico across multiple batch lots.

    Product
    Sermorelin 2000mcg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1211-2022·2022-07-20

    Levocarnitine Injection Recalled Due to Lack of Sterility Assurance

    Tailor Made Compounding is recalling Levocarnitine 500mg/mL vials nationwide due to lack of sterility assurance, a Class II FDA recall.

    Product
    Levocarnitine 500mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1214-2022·2022-07-20

    Compounded Injectable Medication Recalled for Lack of Sterility Assurance

    Tailor Made Compounding is recalling 232 vials of Methionine/Inositol/Choline B12 injectable across the U.S. and Puerto Rico due to lack of assurance of sterility. Patients who received this medication should contact their healthcare provider.

    Product
    Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL, a)10 mL-vial, b) 30 mL-vial, Room Temperature, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1204-2022·2022-07-20

    Compounded Injectable Amino Acid Drug Recalled for Sterility Assurance Issues

    Tailor Made Compounding is recalling 60 GOAL injectable vials nationwide due to lack of sterility assurance, which may pose a contamination risk.

    Product
    GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1200-2022·2022-07-20

    Dexpanthenol Preservative Free Injectable Recalled Due to Sterility Assurance Failure

    Tailor Made Compounding recalls 84 vials of Dexpanthenol Preservative Free due to lack of assurance of sterility. The medication was distributed nationwide and in Puerto Rico.

    Product
    Dexpanthenol Preservative Free 250mg/mL, 2mL-vial, Room Temperature, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1205-2022·2022-07-20

    Glutathione Injectable Compounded Drug Recalled Due to Sterility Assurance Issues

    Tailor Made Compounding recalls Glutathione 200mg/mL injectable vials due to lack of sterility assurance. The FDA Class II recall affects 40 vials distributed nationwide.

    Product
    Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0987-2022·2022-06-15

    B-Complex plus Chromic Chloride injection recall for lack of sterility assurance

    US Specialty Formulations is recalling B-Complex plus Chromic Chloride injectable vials due to lack of assurance of sterility. The product was distributed to medical facilities and physician offices nationwide.

    Product
    B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton, US Specialty Formulations
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0957-2022·2022-06-08

    Hydromorphone Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling Hydromorphone HCl Injection 50 mg/50 mL pre-filled syringes due to lack of sterility assurance. The recalled product was distributed nationwide.

    Product
    Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0968-2022·2022-06-08

    Rocuronium Bromide Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling Rocuronium Bromide Injection pre-filled syringes nationwide due to lack of sterility assurance. Approximately 604,080 syringes are affected.

    Product
    Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0967-2022·2022-06-08

    Phenylephrine HCl Injection Recalled Due to Sterility Assurance Failure

    Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection syringes nationwide because the manufacturer cannot assure the product met sterility standards required for injectable medications.

    Product
    Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0969-2022·2022-06-08

    Succinylcholine Chloride Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center LLC is recalling succinylcholine chloride injection due to lack of sterility assurance. The recall involves 181,560 pre-filled syringes distributed nationwide.

    Product
    Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-920-05
    Category
    Drug
    Distribution
    Distributed nationwide