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.

1126–1150 of 2383

  • SevereFDA (Drugs)·D-1251-2016·2016-07-20

    Medaus Recalls Zinc Sulfate Vials Due to Sterility Concerns

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

    Product
    ZINC SO4 10MG/ML (PF), Vials 2ML, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1340-2016·2016-07-20

    Pharmakon Recalls Vecuronium Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 275 vials of compounded Vecuronium 1mg/mL syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Vecuronium 1mg/mL in Sterile Water ,10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0972-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1308-2016·2016-07-20

    Pharmakon Recalls Fentanyl and Bupivacaine Compounded Syringes for Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 260 syringes of compounded fentanyl and bupivacaine due to a lack of assurance of sterility.

    Product
    Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0826-77
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1306-2016·2016-07-20

    Pharmakon Recalls Fentanyl and Ropivacaine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 50 bags of compounded fentanyl and ropivacaine due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0819-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1246-2016·2016-07-20

    Medaus Recalls Thiamine Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling Thiamine 100 mg/mL vials because the company cannot assure the sterility of the product. The recall covers lots distributed in the U.S., Japan, and New Zealand.

    Product
    THIAMINE 100 MG/ML, 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1216-2016·2016-07-20

    Medaus Recalls Methyl B12 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Methyl B12 10mg/mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.

    Product
    METHYL B12 10MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY
    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-1199-2016·2016-07-20

    Medaus Recalls L-Phenylalanine Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of L-Phenylalanine 15mg/mL vials because the FDA cannot assure the product is sterile.

    Product
    L-PHENYLALANINE 15MG/ML (PF), 50ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1309-2016·2016-07-20

    Pharmakon Recalls Diltiazem HCI Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 10 bags of Diltiazem HCI 250 mg in 5% Dextrose due to a lack of assurance of sterility.

    Product
    Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0853-02
    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
  • SevereFDA (Drugs)·D-1178-2016·2016-07-20

    Medaus Recalls Dexpantenol Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Dexpantenol 250mg/mL vials because the company cannot ensure the product is sterile.

    Product
    DEXPANTHENOL 250MG/ML (PF), In a) 2ML Vials and b) 5ML 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-1257-2016·2016-07-20

    Pharmakon Recalls Bupivacaine Injection Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 130 bags of Bupivacaine 1mg/mL injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.

    Product
    Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0019-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1344-2016·2016-07-20

    Pharmakon Recalls Sufentanil and Bupivacaine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 595 bags of compounded Sufentanil and Bupivacaine due to a lack of assurance of sterility.

    Product
    Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 mL Intravia Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN, NDC 45183-0996-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1303-2016·2016-07-20

    Pharmakon Recalls Norepinephrine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 70 bags of Norepinephrine Bitartrate 8mg in 5% Dextrose due to a lack of assurance of sterility.

    Product
    Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0806-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1288-2016·2016-07-20

    Pharmakon Recalls Bupivacaine HCI Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 40 units of Bupivacaine HCI 0.125% syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0608-75
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1223-2016·2016-07-20

    Medaus Recalls M.I.C B-Complex Vials Due to Sterility Concerns

    Medaus, Inc. is recalling M.I.C B-Complex vials distributed in the U.S., Japan, and New Zealand due to a lack of assurance of sterility.

    Product
    M.I.C B-COMPLEX W/PRES. (BENZYL ETOH 2%) B1-50MG;B2-5-PO4-5MG;B3-50MG;B5-5MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-50MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1307-2016·2016-07-20

    Pharmakon Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Morphine Sulfate syringes because the company cannot guarantee the products are sterile.

    Product
    Morphine Sulfate (Preserved) 2mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 ml BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0823-75
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1320-2016·2016-07-20

    Pharmakon Recalls Fentanyl and Ropivacaine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 20 bags of compounded Fentanyl Citrate and Ropivacaine HCI due to a lack of assurance of sterility.

    Product
    Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 mL bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 5183-0906-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1229-2016·2016-07-20

    Medaus Recalls Sodium Ascorbate Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Sodium Ascorbate 500mg/mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.

    Product
    NA ASCORBATE 500MG/ML NON-CORN (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1289-2016·2016-07-20

    Pharmakon Recalls Cefazolin 2GM Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Cefazolin 2GM in 5% Dextrose 50 mL due to a lack of assurance of sterility. The recall affects 1,450 units distributed nationwide.

    Product
    Cefazolin 2GM added to 5% Dextrose 50 mL USP, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0610-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1272-2016·2016-07-20

    Pharmakon Recalls Norepinephrine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 24 bags of compounded Norepinephrine 16 mg in 0.9% sodium chloride due to a lack of assurance of sterility.

    Product
    Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0174-02
    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