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.

2051–2075 of 2384

  • SevereFDA (Drugs)·D-1218-2014·2014-04-16

    Zions RX Formulations Recalls Bupivacaine Due to Sterility Concerns

    Zions RX Formulations is recalling 60 units of Bupivacaine 3% in Arizona due to poor aseptic practices that compromised sterility assurance.

    Product
    Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1215-2014·2014-04-16

    Zions RX Formulations Recalls Potassium Phosphates Vials Due to Sterility Concerns

    Zions RX Formulations is recalling 95 vials of Potassium Phosphates due to a lack of assurance of sterility caused by poor aseptic practices.

    Product
    Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1214-2014·2014-04-16

    Zions RX Formulations Recalls Magnesium Sulfate Bags Due to Sterility Concerns

    Zions RX Formulations is recalling 861 bags of Magnesium Sulfate in Lactated Ringers due to poor aseptic practices that compromise sterility assurance.

    Product
    Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1217-2014·2014-04-16

    Zions RX Formulations Recalls Sodium Bicarbonate Injectable Units

    Zions RX Formulations is recalling 610 units of Sodium Bicarbonate 8.4% injectable products due to a lack of assurance of sterility.

    Product
    Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1219-2014·2014-04-16

    Zions RX Formulations Recalls Vitamin B-12 Injections Due to Sterility Concerns

    Zions RX Formulations Services LLC is recalling specific lots of Vitamin B-12 injections due to a lack of assurance of sterility resulting from poor aseptic practices.

    Product
    Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1052-2014·2014-02-05

    NuVision Pharmacy Recalls Sermorelin/GHRP-6 Vials Due to Sterility Concerns

    NuVision Pharmacy is recalling 122 vials of Sermorelin/GHRP-6 due to lack of sterility assurance identified during an FDA inspection.

    Product
    Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1037-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling Rohto eye drops because of concerns about sterility controls. The recall covers nationwide distribution and Puerto Rico.

    Product
    ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 10909 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1036-2014·2014-02-05

    Hospira Recalls Heparin Sodium Bags Due to Sterility Concerns

    Hospira is recalling 27,780 bags of Heparin Sodium 2000 USP Units per 1000 mL due to a lack of assurance of sterility and potential leakage from the administrative port.

    Product
    HEPARIN SODIUM — HEPARIN SODIUM (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1041-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling several Rohto eye drop products due to concerns about the quality assurance of sterility controls.

    Product
    ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01074 9, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-428-2014·2014-01-22

    Lidocaine/Sodium Chloride Injectable Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Lidocaine/Sodium Chloride injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-415-2014·2014-01-22

    Cyanocobalamin Injectable Recalled Due to Sterility Assurance Concerns

    Specialty Medicine Compounding Pharmacy is recalling cyanocobalamin injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    Cyanocobalamin, 1000 mcg/ml; injectable, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-421-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Fluorouracil Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Fluorouracil PF 50 mg/mL injectable because sterility cannot be assured after another product was found non-sterile in the same environment.

    Product
    FLUOROURACIL* PF 50 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-443-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Quad Mix Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Quad Mix and Super Quad Mix injectables because sterility cannot be assured after a related product was found non-sterile.

    Product
    QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJECTABLE, QUAD MIX* 0.1 mg/9 mg/1 mg/10 mcg/mL INJECTABLE, SUPER QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, (pavaperine HCl, phentolamine, pr
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-444-2014·2014-01-22

    Sodium Phosphate Injectable Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Sodium Phosphate injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    SODIUM PHOSPHATE* PF 3MMOL/mL INJECTABLE, SODIUM PHOSPHATE* PF(15 mL) 3MMOL/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-439-2014·2014-01-22

    Phenylephrine/Tropicamide Ophthalmic Solution Recalled for Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Phenylephrine/Tropicamide ophthalmic solution because sterility cannot be assured due to environmental contamination risks.

    Product
    Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-430-2014·2014-01-22

    Methocarbamol Injectable Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Methocarbamol 100 mg/mL injectable because sterility cannot be assured after a related product was found non-sterile.

    Product
    METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-427-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Hydroxocobalamin/Thiamine Injectable

    Specialty Medicine Compounding Pharmacy is recalling Hydroxocobalamin/Thiamine Injectable due to lack of assurance of sterility. The product was distributed to healthcare providers in Michigan.

    Product
    HYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-736-2014·2014-01-22

    Sigma-Tau Recalls Oncaspar Injection Due to Sterility Concerns

    Sigma-Tau Pharmaceuticals is voluntarily recalling five lots of Oncaspar Injection because a crack under the crimp seal caused a leak, compromising sterility.

    Product
    PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMACEUTICALS INC, 9841 Washingtonian Blvd, Gaithersburg, MD 20878 NDC 54482-301-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0770-2014·2014-01-22

    Teleflex Recalls Electrosurgical Suction Tubes Due to Sterility Concerns

    Teleflex Medical is recalling 17,450 electrosurgical coagulation suction tubes because sterility cannot be guaranteed. The devices were distributed nationwide.

    Product
    Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 2770. Intended to remove tissue and control bleeding by use of high-frequency electrical current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-405-2014·2014-01-15

    FDA Recalls Papaverine/Phentolamine Injections Due to Sterility Concerns

    The Compounding Center at Blue Ridge is recalling all lots of Papaverine/Phentolamine injections due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-402-2014·2014-01-15

    FDA Recalls PGE Injectable Due to Sterility Assurance Concerns

    The Compounding Center at Blue Ridge is recalling PGE 20 mcg/mL and 40 mcg/mL injectables due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-404-2014·2014-01-15

    Quad Mix Injectable Recalled Due to Sterility Concerns

    The Compounding Center at Blue Ridge is recalling all lots of Quad Mix Injectable due to quality control concerns identified during an FDA inspection.

    Product
    Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-401-2014·2014-01-15

    Triple Mix Injectable Recalled for Lack of Sterility Assurance

    The Compounding Center at Blue Ridge is recalling 92 units of Triple Mix Injectable due to quality control concerns identified during an FDA inspection.

    Product
    Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr Bennett's Triple Rx; Dr Neighbors Triple Rx Injectable; Dr Leatherman's Triple Rx Injectable; Dr Kane's Triple Rx Injectable; Dr Khoudary's Triple Rx Injectable) Rx Only, The Compounding Center at Blue Ri
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-403-2014·2014-01-15

    FDA Recalls Super Triple Mix Injectable Due to Sterility Concerns

    The FDA is recalling all lots of Super Triple Mix Injectable from The Compounding Center at Blue Ridge due to quality control concerns regarding sterility assurance.

    Product
    Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Super Triple Rx Injectable; Dr Tortora's Super Triple Rx Injectable), 5 mL vial, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Drug
    Distribution
    1 state