The Recall Desk

Hazard

Infection Risk recalls

3,438 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,438
Critical
25
Severe
993
Most recent
2026-10-14

Of the 3,438 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 993 (29%) 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 infection risk 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.

776–800 of 3438

  • HighFDA (Drugs)·D-1248-2022·2022-07-27

    Injectable Lidocaine Syringes Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center has recalled 1,380 prefilled lidocaine syringes nationwide due to inability to confirm product sterility.

    Product
    0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1245-2022·2022-07-27

    Nephron Amino Acid Injection Bags Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling 163 bags of Amino Acid Injection due to lack of assurance of sterility. Patients using this intravenous medication should contact their healthcare provider immediately.

    Product
    Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10
    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-1195-2022·2022-07-20

    Ascorbic Acid Injectable Vials Recalled Due to Sterility Assurance Failure

    Tailor Made Compounding is recalling ascorbic acid injectable vials due to lack of sterility assurance. The affected vials were distributed nationwide and in Puerto Rico.

    Product
    Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 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-1220-2022·2022-07-20

    Nandrolone Decanoate Injectable Vials Recalled for Lack of Sterility Assurance

    Tailor Made Compounding is recalling 243 vials of Nandrolone Decanoate injectable medication due to lack of sterility assurance. The affected product was distributed nationwide in the USA and Puerto Rico.

    Product
    Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1219-2022·2022-07-20

    NAD+ Injectable Vials Recalled Due to Lack of Sterility Assurance

    Tailor Made Compounding is recalling 1,856 vials of NAD+ 200mg/mL because the company cannot assure the product meets sterility requirements. The affected vials were distributed nationwide to the United States and Puerto Rico.

    Product
    NAD+ 200mg/mL, 10mL-vial, Refrigerate, 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-1147-2022·2022-06-22

    Medroxyprogesterone acetate injectable vials recalled for lack of sterility assurance

    Sun Pharmaceutical is recalling 26,892 vials of medroxyprogesterone acetate injectable suspension (150 mg/mL) distributed nationwide due to lack of assurance of sterility. The affected lots expire between January and June 2023.

    Product
    medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1143-2022·2022-06-22

    Prefilled Syringes of Medroxyprogesterone Acetate Recalled for Lack of Sterility Assurance

    Afaxys Pharma is recalling 79,339 prefilled syringes of medroxyprogesterone acetate because the manufacturer could not assure sterility. The syringes were distributed nationwide.

    Product
    medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Distributed by: Afaxys Pharma, LLC, Charleston, SC, 29403, USA, Product…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1248-2022·2022-06-15

    Getinge CM320-2 Surgical Instrument Washer Disinfector Recalled for Incomplete Installation Verification

    Getinge recalls its CM320-2 washer disinfector due to unverified or incomplete installation, which could cause skin burns, electric shock, smoke inhalation, or crush injuries. Four units were distributed across seven US states.

    Product
    Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1249-2022·2022-06-15

    Getinge CM320 WUWD Washer Disinfector Installation Verification Issue Recall

    The FDA is recalling 11 Getinge CM320 WUWD washer-disinfectors used for surgical instrument processing. Installation verification was not properly documented or completed, potentially creating risks of electrical shock, burns, and other injuries.

    Product
    Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1216-2022·2022-06-08

    Ratcheting Screwdriver Handle in Surgical Kit Unable to Meet Sterilization Requirements

    Tornier's Ratcheting Screwdriver Handle in the Aequalis Perform Reversed kit cannot meet sterilization requirements when sterilized per instructions in an Aesculap container. The company is recalling 1066 units distributed nationwide.

    Product
    Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0952-2022·2022-06-08

    EPINEPHrine Pre-filled Syringes Recalled for Sterility Assurance Issue

    Nephron Sterile Compounding Center is recalling 35,850 pre-filled syringes of EPINEPHrine Injection due to lack of sterility assurance. The affected syringes were distributed nationwide.

    Product
    EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 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: 69374-544-10
    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
  • 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-0954-2022·2022-06-08

    Fentanyl Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center has recalled 3,532 bags of fentanyl citrate injection due to lack of sterility assurance. The affected lots (FN1088A and FN1089A) were distributed nationwide.

    Product
    Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0963-2022·2022-06-08

    Neostigmine Methylsulfate Injection Recalled Due to Sterility Assurance Failure

    Nephron Sterile Compounding Center is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The compounded injectable drug may not meet sterile product standards.

    Product
    Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 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: 69374-902-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0943-2022·2022-06-01

    Ondansetron Hydrochloride vials recalled due to sterility assurance concerns

    Olympia Compounding Pharmacy recalls 911 vials of Ondansetron Hydrochloride (1 mg/mL) due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.

    Product
    Ondansetron Hydrochloride, 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0127-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0900-2022·2022-06-01

    Compounded Injectable Drug Recalled for Lack of Sterility Assurance

    Olympia Compounding Pharmacy is recalling SB-5, a multi-dose injectable medication, due to lack of assurance of sterility. The product was distributed nationwide; patients should contact their healthcare provider immediately.

    Product
    SB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0024-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0917-2022·2022-06-01

    Alpha Lipoic Acid injection vials recalled for sterility assurance defect

    Olympia Compounding Pharmacy is recalling 3,286 vials of Alpha Lipoic Acid 25 mg/mL due to inability to assure sterility. Patients should contact their healthcare provider to verify their medication and discuss alternatives.

    Product
    Alpha Lipoic Acid 25 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0076-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0942-2022·2022-06-01

    FDA Recalls Olympia Vita-Complex Injection Due to Sterility Concerns

    Olympia Compounding Pharmacy has recalled 8,664 vials of Olympia Vita-Complex B-vitamin injection nationwide due to lack of assurance of sterility. The affected multi-dose vials may pose an infection risk to patients who receive the product.

    Product
    Olympia Vita-Complex Thiamine HCL (B1) 100 mg/mL Niacinamide (B3) 100 mg/mL Riboflavin 5 P04 (B2) 2 mg/mL Dexpanthenol (B5) 2 mg/mL Pyridoxine HCL (B6) 2 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0914-2022·2022-06-01

    Injectable Testosterone Recalled for Lack of Sterility Assurance

    Olympia Compounding Pharmacy is recalling 520 vials of Ultratest testosterone injectable due to lack of sterility assurance. The recall affects distribution nationwide in the USA, Puerto Rico, and US Virgin Islands.

    Product
    Ultratest Testosterone Cypionate 160 mg/mL Testosterone Propionate 40 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0058-10
    Category
    Drug
    Distribution
    Distributed nationwide