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.

1176–1200 of 2384

  • SevereFDA (Drugs)·D-1301-2016·2016-07-20

    Pharmakon Recalls Epinephrine Syringes Due to Sterility Concerns

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

    Product
    Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0800-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1217-2016·2016-07-20

    Medaus Recalls Methyl B12 Vials Due to Sterility Concerns

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

    Product
    METHYL B12 1000MCG/ML IN NACL 0.9% (PF), 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1312-2016·2016-07-20

    Pharmakon Recalls Hydromorphone IV Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 675 units of compounded Hydromorphone HCI IV bags due to a lack of assurance of sterility.

    Product
    Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060 , NDC 45183-0865-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1193-2016·2016-07-20

    Medaus Recalls Hydroxy B12 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific vials of Hydroxy B12 injection due to a lack of assurance of sterility. The affected product was distributed in the U.S., Japan, and New Zealand.

    Product
    HYDROXY B12 1000MCG/ML IN NACL 0.9% (PF), 1ML Vials, MEDAUS PHARMACY
    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-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-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-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-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-1186-2106·2016-07-20

    Medaus Recalls GABA 50mg/mL Vials Due to Sterility Concerns

    Medaus, Inc. is recalling GABA 50mg/mL vials because the product lacks assurance of sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    GABA 50MG/ML (PF), 50ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1207-2016·2016-07-20

    Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Lipo-Injection vials because the company cannot ensure the product is sterile.

    Product
    LIPO-INJECTION W/METHYL B12 500 MCG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1290-2016·2016-07-20

    Pharmakon Recalls Provocholine Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 142 units of Provocholine pre-diluted syringes nationwide due to a lack of assurance of sterility.

    Product
    Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0674-80
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1221-2016·2016-07-20

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

    Medaus, Inc. is recalling M.I.C./B-Complex (PF) vials because the company cannot assure the sterility of the product. The recall affects 3,000 mL in vials distributed in the U.S., Japan, and New Zealand.

    Product
    M.I.C./B-COMPLEX (PF) B1-50MG;B2-5-PO4-5MG;B3-50MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-5MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1328-2016·2016-07-20

    Pharmakon Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 340 units of Morphine Sulfate syringes due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD locations.

    Product
    Morphine Sulfate 5mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0935-67
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1209-2016·2016-07-20

    Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Lipo-Injection vials because the company cannot guarantee the product is sterile.

    Product
    LIPO-INJECTION W/LIDOCAINE NO METHIONINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG,INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1256-2016·2016-07-20

    Pharmakon Recalls Phenylephrine Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Phenylephrine 40 mcg/mL injection syringes due to a lack of assurance of sterility.

    Product
    Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0011-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1317-2016·2016-07-20

    Pharmakon Recalls Morphine Sulfate IV Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 45 units of Morphine Sulfate IV bags due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0877-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1233-2016·2016-07-20

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

    Medaus, Inc. is recalling Proline 100mg/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
    PROLINE 100MG/ML (PF), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1204-2016·2016-07-20

    Medaus Recalls Lipo B Cyano Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Lipo B Cyano 1mg/mL vials because the company cannot ensure the product is sterile.

    Product
    LIPO B CYANO 1MG/ML W/PRES. (BENZYL ETOH 1%) METHIONINE 25MG, INOSITOL 50MG, CHOLINE CHL-50MG, CYANO B-12-100MCG, BENZYL ALCOHOL 1%/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1295-2016·2016-07-20

    Pharmakon Recalls Oxytocin Infusion Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 384 units of compounded Oxytocin 30 Units in 0.9% Sodium Chloride due to a lack of assurance of sterility.

    Product
    Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0735-03
    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-1172-2016·2016-07-20

    Medaus Recalls B-Complex 50 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling B-Complex 50 in NaCl 0.9% vials because the company cannot assure the sterility of the product.

    Product
    B-COMPLEX 50 IN NACL 0.9% (PF) B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1267-2016·2016-07-20

    Pharmakon Recalls Midazolam Syringes Due to Sterility Assurance Concerns

    Pharmakon Pharmaceuticals is recalling 40 vials of compounded Midazolam (PF) 5mg/ml 25 mL BD syringes due to a lack of assurance of sterility.

    Product
    Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0138-67
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1266-2016·2016-07-20

    Pharmakon Recalls Epinephrine Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 400 syringes of compounded Epinephrine due to a lack of assurance of sterility. The products were distributed nationwide to VA and DOD facilities.

    Product
    Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0135-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1171-2016·2016-07-20

    Medaus Recalls B-Complex Vials Due to Sterility Concerns

    Medaus, Inc. is recalling B-Complex Without B12 vials because the FDA could not ensure the product was sterile. The recall covers 5 mL and 10 mL vials distributed in the U.S., Japan, and New Zealand.

    Product
    B-COMPLEX WITHOUT B12 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide