The Recall Desk

Hazard

Lack Of Sterility recalls

1,423 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,423
Critical
3
Severe
1,055
Most recent
2026-10-14

Of the 1,423 lack of sterility recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,055 (74%) are Severe.

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.

1076–1100 of 1423

  • SevereFDA (Drugs)·D-1183-2016·2016-07-20

    Medaus Recalls Estradiolval and Testosterone Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Estradiolval and testosterone vials because the company cannot ensure the product is sterile.

    Product
    ESTRADIOLVAL 3MG/TEST CYP 35MG/ TEST PROP 35MG/ML W/PRES. (BENZYL ETOH 2%), 3ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1282-2016·2016-07-20

    Pharmakon Recalls Magnesium Sulfate Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 72 bags of Magnesium Sulfate in Lactated Ringers due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0407-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1280-2016·2016-07-20

    Pharmakon Recalls Cefazolin Sodium Chloride Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 18 units of Cefazolin 3GM in 0.9% Sodium Chloride bags due to a lack of assurance of sterility.

    Product
    Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0223-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1240-2016·2016-07-20

    Medaus Recalls Taurine Vials Due to Lack of Sterility Assurance

    Medaus, Inc. is recalling Taurine 50 mg/mL vials because the company cannot assure the product is sterile.

    Product
    TAURINE 50 MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1212-2016·2016-07-20

    Medaus Recalls Manganese Chloride Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Manganese Chloride 0.1mg/mL vials because the company cannot guarantee the product is sterile.

    Product
    MANGANESE CHL 0.1MG/ML PF, 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1249-2016·2016-07-20

    Medaus Recalls Tryptophan Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling Tryptophan 10mg/mL vials because the company cannot ensure the product is sterile. The recall affects 10mL and 50mL vials distributed in the U.S., Japan, and New Zealand.

    Product
    TRYPTOPHAN 10MG/ML (PF), In a) 10ML Vials and b) 50ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1175-2016·2016-07-20

    Medaus Recalls B-Complex and Lidocaine Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of B-Complex with Methyl B12 and Lidocaine vials because the company cannot guarantee the product is sterile.

    Product
    B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, LIDOCAINE 1%, METHYL B12 1MG/ML, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1211-216·2016-07-20

    Medaus Recalls Magnesium Chloride Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Magnesium Chloride 200mg/mL vials because the company cannot assure the sterility of the product.

    Product
    MAGNESIUM CHL 200MG/ML (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1247-2016·2016-07-20

    Medaus Recalls Thiamine Vials Due to Lack of Sterility Assurance

    Medaus, Inc. is recalling specific lots of Thiamine 100 mg/mL vials because the company cannot guarantee the product is sterile.

    Product
    THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1208-2016·2016-07-20

    Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Lipo-Injection vials because the FDA determined there is a lack of assurance of sterility.

    Product
    LIPO-INJECTION W/METHYL B12 500 MCG/CARNITINE/NO VIT C W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, CARNITINE 25MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1226-2016·2016-07-20

    Medaus Recalls Minoxidil Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling specific lots of Minoxidil 0.5% vials because the company cannot ensure the product is sterile.

    Product
    MINOXIDIL 0.5% W/PRES. (BENZYL ETOH 2%), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1281-2016·2016-07-20

    Pharmakon Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 25 units of Morphine Sulfate syringes because the company cannot guarantee the products are sterile.

    Product
    Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0322-78
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1334-2016·2016-07-20

    Pharmakon Recalls Ondansetron Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 2,300 units of compounded Ondansetron 2mg/mL syringes because the company cannot ensure the product is sterile.

    Product
    Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0957-69
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1336-2016·2016-07-20

    Pharmakon Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Ephedrine Sulfate 5 mg/mL syringes because the company cannot guarantee the products are sterile.

    Product
    Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0961-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1275-2016·2016-07-20

    Pharmakon Recalls Promethazine IV Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 725 units of compounded Promethazine IV bags due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0186-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1181-2016·2016-07-20

    Medaus Recalls DMSO 99.9 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling DMSO 99.9 vials because the company cannot ensure the product is sterile. The recall covers 5 mL and 10 mL vials distributed in the U.S., Japan, and New Zealand.

    Product
    DMSO 99.9 (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1333-2016·2016-07-20

    Pharmakon Recalls Rocuronium Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 1,925 vials of Rocuronium 10 mg/mL syringes because the company cannot guarantee the product is sterile.

    Product
    Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0955-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1179-2016·2016-07-20

    Medaus Recalls Dexpantenol Vials Due to Lack of Sterility Assurance

    Medaus, Inc. is recalling Dexpantenol 250mg/mL vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    DEXPANTHENOL 250MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1230-2016·2016-07-20

    Medaus Recalls Nandrolone Decanoate Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Nandrolone Decanoate 200mg/mL vials because the company cannot guarantee the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    NANDROLONE DEC 200MG/ML W/PRES. (BENZYL ETOH 10%), In a) 2ML Vials, b) 4ML Vials, and c) 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1182-2016·2016-07-20

    Medaus Recalls EDTA Disodium Vials Due to Sterility Concerns

    Medaus, Inc. is recalling EDTA Disodium 15% vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    EDTA DISODIUM 15% (150MG/ML), 20ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1327-2016·2016-07-20

    Pharmakon Recalls Phenylephrine Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 800 syringes of Phenylephrine HCI 100mcg/mL due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0934-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1319-2016·2016-07-20

    Pharmakon Recalls Fentanyl and Bupivacaine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 870 bags of compounded Fentanyl and Bupivacaine due to a lack of assurance of sterility.

    Product
    Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, 150 mL lntravia bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0905-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1191-2016·2016-07-20

    Medaus Recalls Hydroxy B12 Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling Hydroxy B12 5mg/mL vials because the company cannot ensure the product is sterile.

    Product
    HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1332-2016·2016-07-20

    Pharmakon Recalls Lidocaine Syringes Due to Sterility Assurance Concerns

    Pharmakon Pharmaceuticals is recalling 50 vials of Lidocaine 2% syringes because the company cannot ensure the products are sterile.

    Product
    Lidocaine 2%, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0946-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1254-2016·2016-07-20

    Medaus Recalls Hydrochloric Acid Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of HCL 2MG/ML (PF) 5ML Vials because the company cannot ensure the product is sterile.

    Product
    HCL 2MG/ML (PF), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide