The Recall Desk

Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,691
Critical
12
Severe
931
Most recent
2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 failure 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.

1001–1025 of 1691

  • SevereFDA (Drugs)·D-0759-2017·2017-05-24

    Key Pharmacy Recalls Sterile Ophthalmic Compounded Drug Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling a specific lot of sterile compounded ophthalmic drug due to a lack of assurance of sterility.

    Product
    VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multiple Dose bottle, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0766-2017·2017-05-24

    Key Pharmacy Recalls GSH/NAC Inhalation Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling GSH/NAC inhalation solution because the firm cannot assure the product is sterile.

    Product
    GSH/NAC INH 2ML PV 60/100MG/ML SOLN, Inhalation Solution, 60mg/100mg/mL, Rx only, 5mL Plastic/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0714-2017·2017-05-24

    Key Pharmacy Recalls DMPS Acid Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 214 vials of DMPS Acid injections because the firm cannot assure the sterility of the product.

    Product
    DMPS ACID *5ML* SDV 50MG/ML INJ, Injection, 50mg/ml, Rx only, 5 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0780-2017·2017-05-24

    Key Pharmacy Recalls Sodium Chloride Inhalation Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Sodium Chloride Inhalation Solution because the firm cannot assure the sterility of the product.

    Product
    SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0728-2017·2017-05-24

    Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot guarantee the products are sterile.

    Product
    HYDROXO-B12 5ML PBF MDV (CALIF) 10MG/ML INJ, Injection, 10mg/mL, RX only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0777-2017·2017-05-24

    Key Pharmacy Recalls Pyridoxal-5-Phosphate Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling Pyridoxal-5-Phosphate 50mg/mL injection vials due to a lack of assurance of sterility.

    Product
    PYRIDOXAL-5-PHOS 5ML MDV 50MG/ML INJ, 50mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0721-2017·2017-05-24

    Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot ensure the products are sterile.

    Product
    HYDROXO-B12 *1ML* SDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0732-2017·2017-05-24

    Key Pharmacy Recalls PGE1 Injection Due to Sterility Assurance Concerns

    Key Pharmacy and Compounding Center is recalling PGE1 5ML MDV INJ, 40mcg/mL, due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.

    Product
    PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0789-2017·2017-05-24

    Baxter Recalls Milrinone Lactate Injection Due to Sterility Concerns

    Baxter Healthcare is recalling Milrinone Lactate in Dextrose Injection because customer complaints reported leaks, creating a lack of assurance of sterility.

    Product
    MILRINONE LACTATE IN DEXTROSE — MILRINONE LACTATE IN DEXTROSE (MILRINONE LACTATE)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0723-2017·2017-05-24

    Key Pharmacy Recalls Hydroxo-B12 Inhalation Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling Hydroxo-B12 inhalation solution because the firm cannot assure the sterility of the product.

    Product
    HYDROXO-B12 INH PF GV 5MG/ML SOLN, Inhalation Solution, 5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0722-2017·2017-05-24

    Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot assure the sterility of the products.

    Product
    HYDROXO-B12 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 2ML SDV 10MG/ML INJ, Injection, 10mg/mL, RX only, 2 mL glass/ Single Dose vial.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0781-2017·2017-05-24

    Key Pharmacy Recalls SOD Phenylbutyrate Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 91 vials of SOD Phenylbutyrate injections due to a lack of assurance of sterility.

    Product
    SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0785-2017·2017-05-24

    Key Pharmacy Recalls Vitamin D3 Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling Vitamin D3 in Olive Oil SDV 100,000U/mL Injection due to a lack of assurance of sterility.

    Product
    VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL, Rx only, packaged in 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0682-2017·2017-05-03

    Isomeric Pharmacy Recalls Methylprednisolone Acetate Injection Vials for Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 2,352 vials of Methylprednisolone Acetate and Lidocaine HCl injection due to production processes that cannot assure sterility.

    Product
    Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1011, barcode 3 70285 10111 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0687-2017·2017-05-03

    Isomeric Pharmacy Recalls Phenylephrine and Tropicamide Ophthalmic Drops

    Isomeric Pharmacy Solution, LLC is recalling 5,165 bottles of Phenylephrine 2.5% and Tropicamide 1% ophthalmic drops due to a lack of assurance of sterility.

    Product
    Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0683-2017·2017-05-03

    Isomeric Pharmacy Recalls Triamcinolone Acetonide Injection Vials for Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 2,335 vials of Triamcinolone Acetonide and Lidocaine HCl injection due to production processes that cannot assure sterility.

    Product
    Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1020, barcode 3 70285 10201 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1759-2017·2017-04-19

    ConMed Recalls Sterile Handpiece Sheaths Packaged as Non-Sterile

    ConMed is recalling sterile handpiece sheaths that were incorrectly packaged with non-sterile units. This error could lead to the use of non-sterile sheaths in medical procedures.

    Product
    Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 230 VOLTS AC, REF/Catalog Number 7-900-230, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0584-2017·2017-03-22

    Synergy Rx Recalls HCG Products Due to Sterility Assurance Issues

    Synergy Rx is recalling all lots of HCG products nationwide due to a lack of assurance of sterility and CGMP deviations.

    Product
    HCG in all strength including: 2,400, 9600,12,000 UNIT POWDER VIAL DROPS, HCG 11,000/B-12 UNITS SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0553-2017·2017-03-22

    Synergy Rx Clarifying Cream Recalled for Sterility Assurance Failures

    Synergy Rx is recalling Clarifying Cream due to a lack of assurance of sterility and CGMP deviations.

    Product
    CLARIFYING CREAM (Retinoic acid 0.025%, Salicylic Acid 1%, Green tea powder, Ascorbic acid 2%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0535-2017·2017-03-22

    Synergy Rx Recalls Clobetasol Products Due to Sterility Assurance Concerns

    Synergy Rx is recalling Clobetasol 0.05% products because the FDA identified a lack of assurance of sterility and CGMP deviations.

    Product
    CLOBETASOL 0.05% IN OLEA BASE, CLOBETASOL 0.05% IN OROBASE, CLOBETASOL 0.05% OINTMENT, CLOBETASOL 0.05%/ SODIUM, SULFACETAMIDE 10% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0585-2017·2017-03-22

    Synergy Rx Recalls Human Chorionic Gonadotropin Tablets Due to Sterility Concerns

    Synergy Rx is recalling Human Chorionic Gonadotropin tablets because the product lacks assurance of sterility and has CGMP deviations.

    Product
    HUMAN CHORIONIC GONADOTROPIN in 300IU and 500 IU TABLETS, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0578-2017·2017-03-22

    Synergy Rx Recalls VI PEEL Chemical Peel Due to Sterility Concerns

    Synergy Rx is recalling VI PEEL chemical peel products nationwide due to a lack of assurance of sterility and CGMP deviations.

    Product
    VI PEEL (Sal Acid 2%, TCA 17%, Phenol 7%, Retinoic Acid 0.4%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0528-2017·2017-03-22

    Synergy Rx Recalls Minoxidil Products Due to Sterility Assurance Concerns

    Synergy Rx is recalling Minoxidil and Minoxidil/Retinoic Acid products nationwide due to a lack of assurance of sterility and CGMP deviations.

    Product
    MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.025, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0561-2017·2017-03-22

    Synergy Rx Recalls Jessner's Peel Due to Sterility Assurance Concerns

    Synergy Rx is recalling all lots of Jessner's Peel because the product lacks assurance of sterility and has CGMP deviations.

    Product
    JESSNERS PEEL (salicylic Acid 14% rescorcinol 14%, Lactic acid 14%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0586-2017·2017-03-22

    Synergy Rx Recalls Hydroquinone Cream Due to Sterility Assurance Concerns

    Synergy Rx is recalling Hydroquinone Cream in all strengths due to a lack of assurance of sterility and CGMP deviations.

    Product
    HYDROQUINONE CREAM in all strengths including: 4%, 5%, 6%, 7%, 8%,10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide