The Recall Desk

Hazard

Sterility recalls

2,384 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,384
Critical
1
Severe
2,114
Most recent
2026-09-09

Of the 2,384 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 2,114 (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.

1201–1225 of 2384

  • SevereFDA (Drugs)·D-1291-2016·2016-07-20

    Pharmakon Recalls Fentanyl Citrate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Fentanyl Citrate syringes because the company cannot ensure the products are sterile.

    Product
    Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0683-68
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1248-2016·2016-07-20

    Medaus Recalls TMG 100 mg/mL Vials Due to Sterility Concerns

    Medaus, Inc. is recalling TMG 100 mg/mL vials because the product lacks assurance of sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    TMG 100 MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1194-2016·2016-07-20

    Medaus Recalls L-Carnitine Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of L-Carnitine 100mg/mL vials because the company cannot ensure the product is sterile.

    Product
    L-CARNITINE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1318-2016·2016-07-20

    Pharmakon Recalls Vancomycin HCL 1.25 GM Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 216 units of Vancomycin HCL 1.25 GM in 5% Dextrose bags due to a lack of assurance of sterility.

    Product
    Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0885-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1197-2016·2016-07-20

    Medaus Recalls L-Carnitine Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling L-Carnitine 500mg/mL vials because the company cannot assure the product's sterility. The recall covers products distributed in the U.S., Japan, and New Zealand.

    Product
    L-CARNITINE 500MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1313-2016·2016-07-20

    Pharmakon Recalls Atropine Sulfate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 400 units of Atropine Sulfate syringes because the company cannot ensure the products are sterile.

    Product
    Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0867-71
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1299-2016·2016-07-20

    Pharmakon Recalls Oxytocin Lactated Ringers Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 384 units of compounded Oxytocin in Lactated Ringers due to a lack of assurance of sterility.

    Product
    Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0769-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1173-2016·2016-07-20

    Medaus Recalls B-Complex 50 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of B-Complex 50 vials because the company cannot ensure the product is sterile.

    Product
    B-COMPLEX 50 IN NACL 0.9% W/PRES., (BENZYL ETOH 2%), B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1237-2016·2016-07-20

    Medaus Recalls Riboflamin Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling specific lots of Riboflavin 10mg/mL vials because the company cannot ensure the product is sterile.

    Product
    RIBOFLAVIN 10MG/ML (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1214-2016·2016-07-20

    Medaus Recalls Methyl B12 Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling Methyl B12 1000mcg/mL vials distributed in the U.S., Japan, and New Zealand due to a lack of assurance of sterility.

    Product
    METHYL B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01% IN NACL 0.9%, In a) 2ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1236-2016·2016-07-20

    Medaus Recalls Pyridoxine HCL Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Pyridoxine HCL 100mg/mL vials because the company cannot ensure the product is sterile.

    Product
    PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2053-2016·2016-07-06

    Nephron Recalls Sodium Chloride Inhalation Solution Due to Sterility Concerns

    Nephron Pharmaceuticals is recalling 11,208 cartons of Sodium Chloride Inhalation Solution because internal dye tests failed to confirm vial integrity.

    Product
    Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indica
    Category
    Medical Device
    Distribution
    36 states
  • SevereFDA (Drugs)·D-0984-2016·2016-06-15

    Estradiol Valerate Recall Due to Sterility Assurance Concerns

    Well Care Compounding Pharmacy is recalling Estradiol Valerate 40mg/mL vials because FDA inspections found GMP violations that may affect sterility.

    Product
    ESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1005-2016·2016-06-15

    Phosphatidylcholine/Deoxycholic Acid Injection Recalled for Sterility Concerns

    Well Care Compounding Pharmacy is recalling 869 vials of Phosphatidylcholine/Deoxycholic Acid due to FDA inspection findings regarding sterility assurance.

    Product
    PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0983-2016·2016-06-15

    Estradiol Valerate Recall Due to Sterility Assurance Concerns

    Well Care Compounding Pharmacy is recalling Estradiol Valerate 20mg/mL vials due to GMP violations affecting sterility.

    Product
    ESTRADIOL VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0997-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Injectable Vitamin Mixture for Sterility Concerns

    Well Care Compounding Pharmacy is recalling 869 vials of a compounded injectable vitamin mixture due to FDA inspection findings that raised concerns about product sterility.

    Product
    MB 12/HXB 12/FA/P5P/(LIDO 0.1 %), 2MG/2MCi/20MG/6.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0978-2016·2016-06-15

    FDA Recalls 17-0H Progesterone Vials Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling 17-0H Progesterone vials because FDA inspections found GMP violations that may affect sterility.

    Product
    17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1027-2016·2016-06-15

    FDA Recalls Itraconazole and Mupirocin Nasal Spray Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray because FDA inspections found GMP violations that may affect sterility.

    Product
    ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1000-2016·2016-06-15

    Methylcobalamin Injection Recalled Due to Sterility Assurance Concerns

    Well Care Compounding Pharmacy is recalling Methylcobalamin 1 mg/mL vials because FDA inspections found GMP violations that may impact product sterility.

    Product
    METHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1002-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Methylcobalamin/Folic Acid Vials

    Well Care Compounding Pharmacy is recalling Methylcobalamin/Folic Acid vials due to GMP violations that may impact sterility.

    Product
    METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1016-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls TRI-MIX # 1 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling TRI-MIX # 1 vials because FDA inspections found violations that may affect product sterility.

    Product
    TRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1020-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls TRI-MIX # 5 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling TRI-MIX # 5 vials because FDA inspections found GMP violations that may affect sterility.

    Product
    TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1024-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Vitamin B Complex Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Vitamin B Complex # 3 vials because FDA inspections found GMP violations that may affect sterility.

    Product
    VITAMIN B COMPLEX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1026-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Otic Solution Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling specific lots of Clotrimazole 1%/Betamethasone Dipropionate 0.05% Otic Solution because FDA inspections found GMP violations that may affect sterility.

    Product
    CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state