The Recall Desk

Hazard

Lack Of Sterility recalls

1,417 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,417
Critical
3
Severe
1,048
Most recent
2026-07-29

Of the 1,417 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 1,048 (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 1417

  • SevereFDA (Drugs)·D-1225-2016·2016-07-20

    Medaus Recalls M.I.C 25/50/50 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling M.I.C 25/50/50 vials because the product lacks assurance of sterility. The recall affects 2,000 mL in vials distributed in the U.S., Japan, and New Zealand.

    Product
    M.I.C 25/50/50 W/METHYL B12 1MG/PYRIDOXAL 50MG/ML (PF), 1ML 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-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-1321-2016·2016-07-20

    Pharmakon Recalls Bupivacaine HCI Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Bupivacaine HCI 0.125% bags due to a lack of assurance of sterility. The recall affects 55 units distributed nationwide.

    Product
    Bupivacaine HCI 0.125% in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0909-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1274-2016·2016-07-20

    Pharmakon Recalls Methohexital Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 225 syringes of Methohexital (Brevital Sodium) 10 mg/mL because the company cannot ensure the product is sterile.

    Product
    Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0180-72
    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-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-1324-2016·2016-07-20

    Pharmakon Recalls Phenylephrine Syringes Due to Sterility Assurance Concerns

    Pharmakon Pharmaceuticals is recalling Phenylephrine HCI syringes because the company cannot ensure the products are sterile.

    Product
    Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0927-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1213-2016·2016-07-20

    Medaus Recalls Manganese Sulfate Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Manganese Sulfate vials because the company cannot guarantee the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    MANGANESE SO4 0.1MG/ML (PF), In a) 2MLVials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1259-2016·2016-07-20

    Pharmakon Recalls Fentanyl Citrate Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Fentanyl Citrate 50 mcg/ml injections due to a lack of assurance of sterility. The recall affects 4,050 syringes distributed nationwide and to specific VA/DOD facilities.

    Product
    Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0100-69
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1224-2016·2016-07-20

    Medaus Recalls M.I.C 25/50/50 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling M.I.C 25/50/50 vials because the company cannot guarantee the product is sterile.

    Product
    M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50/MG/ML, In a) 5ML Vials and b) 10ML 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-1270-2016·2016-07-20

    Pharmakon Recalls Fentanyl and Bupivacaine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 105 bags of compounded Fentanyl Citrate and Bupivacaine due to a lack of assurance of sterility.

    Product
    Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0171-01
    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-1180-2016·2016-07-20

    Medaus Recalls DMPS 50mg/mL Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling DMPS 50mg/mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.

    Product
    DMPS 50MG/ML (PF), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1293-2016·2016-07-20

    Pharmakon Recalls Hydromorphone PCA Vials Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 100 vials of Hydromorphone HCI 0.2mg/ml PCA solution due to a lack of assurance of sterility.

    Product
    HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0702-68
    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-1205-2016·2016-07-20

    Medaus Recalls Lipo-Boost Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling Lipo-Boost vials because the company cannot guarantee the product's sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    LIPO-BOOST W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-52MG, METHYL, B12-500MCG, CARNITINE 50 MG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE 30MG/ML, In a) 3ML Vials and b) 5ML Vials, MEDAUS PHARMACY
    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-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-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-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-1195-2106·2016-07-20

    Medaus Recalls L-Carnitine Vials Due to Sterility Concerns

    Medaus, Inc. is recalling L-Carnitine 50mg/mL vials because the company cannot ensure the product is sterile. The recall covers distribution in the U.S., Japan, and New Zealand.

    Product
    L-CARNITINE 50MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
    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-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