The Recall Desk

Hazard

Sterility Assurance recalls

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

What the numbers show

Total
664
Critical
0
Severe
262
Most recent
2026-10-21

Of the 664 sterility assurance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 262 (39%) 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 assurance 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.

601–625 of 664

  • SevereFDA (Drugs)·D-0211-2015·2014-11-12

    FDA Recalls Papaverine HCL Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Papaverine HCL injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    PAPAVERINE HCL, with preservative, 30 mg/mL, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0206-2015·2014-11-12

    Mitomycin Injectable Vials Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Mitomycin injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    MITOMYCIN, 0.2mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0190-2015·2014-11-12

    FDA Recalls Ganciclovir Syringes Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling 40 syringes of Ganciclovir due to quality control issues affecting sterility assurance found during an FDA inspection.

    Product
    GANCICLOVIR -preservative free, 2mg/0.1mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0184-2015·2014-11-12

    FDA Recalls Copper Sulfate Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Copper Sulfate injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    COPPER (SULF), 0.4 mg/mL, injectable, 20 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0198-2015·2014-11-12

    FDA Recalls Hydroxocobalamin Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Hydroxocobalamin (B12) injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    HYDROXOCOBALAMIN-preservative free (B12), 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0226-2015·2014-11-12

    FDA Recalls Trience Injectable Syringes Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Trience 8mg/2.0mL injectable syringes due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    TRIESENCE, 8mg/2.0mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0209-2015·2014-11-12

    FDA Recalls Injectable Papaverine HCL/Phentolamine/Prostaglandin Due to Sterility Concerns

    Oregon Compounding Centers is recalling specific lots of injectable Papaverine HCL/Phentolamine/Prostaglandin due to quality control issues affecting sterility assurance.

    Product
    PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or 1.7 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0181-2015·2014-11-12

    Recall of Chorionic Gonadotropin Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling 145 vials of Chorionic Gonadotropin due to quality control issues affecting sterility assurance.

    Product
    CHORIONIC GONADOTROPIN, 4000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0217-2015·2014-11-12

    FDA Recalls Compounded Injectable Drug Due to Sterility Concerns

    Oregon Compounding Centers is recalling Papaverine/Phentolamine/Prostaglandin injectable vials due to quality control issues affecting sterility assurance.

    Product
    PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.44mg/0.64mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0201-2015·2014-11-12

    FDA Recalls Lidoaine HCL Solution Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Lidoaine HCL solution for irrigation due to quality control issues affecting sterility assurance.

    Product
    LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0214-2015·2014-11-12

    FDA Recalls Papaverine Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Papaverine HCL/Phentolamine/Prostaglandin injectable vials due to quality control issues affecting sterility assurance.

    Product
    PAPAVERINE HCL/PHENTOLAMINE/PROSTAGLANDIN, 27.7mg/0.45mg/45.45mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0173-2015·2014-11-12

    Alprostadil Injectable Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Alprostadil injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    ALPROSTADIL, 10 mcg/mL, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0221-2015·2014-11-12

    FDA Recalls Pyridoxine HCL Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Pyridoxine HCL injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    PYRIDOXINE HCL, with preservative, 100 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0207-2015·2014-11-12

    Mitomycin Injectable Vials Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Mitomycin injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    MITOMYCIN, 0.3mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0227-2015·2014-11-12

    Vancomycin Injectable Syringes Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Vancomycin injectable syringes due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0186-2015·2014-11-12

    FDA Recalls Dexpantenol Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Dexpantenol injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    DEXPANTHENOL with preservative, 250 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0224-2015·2014-11-12

    Testosterone Cypionate Injectable Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Testosterone Cypionate injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    TESTOSTERONE CYPIONATE (SESAME OIL/CMPD), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0213-2015·2014-11-12

    FDA Recalls Papaverine Injection Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Papaverine HCL/Phentolamine Mes/Prostaglandin injections due to quality control issues affecting sterility assurance.

    Product
    PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0191-2015·2014-11-12

    Ganciclovir Syringes Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Ganciclovir syringes due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    GANCICLOVIR, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0222-2015·2014-11-12

    Sodium Chloride Inhalation Solution Recalled for Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Sodium Chloride Inhalation 7% solution due to quality control issues affecting sterility assurance.

    Product
    SODIUM CHLORIDE INHALATION, 7%, Solution for inhalation, 3 mL plastic vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0088-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including hydromorphone/clonidine/bupivacaine, due to quality control observations that risk sterility assurance.

    Product
    Hydromorphone/clonidine/bupivacaine 12 mg/600 mcg/0.2 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0116-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.

    Product
    PGE 20 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0089-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations for Sterility Assurance Concerns

    Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.

    Product
    Hydromorphone/bupivacaine (PF) 0.5 mg/0.2 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0107-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Injectable Preparations for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile injectable preparations due to quality control observations that risk sterility assurance.

    Product
    "NB2014" 30 mg/6 mg/300 mcg/0.3 mg/mL (phentolamine mesylate, papaverine, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0123-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Polyhexamethylene biguanide 2% stock solution, due to quality control issues affecting sterility assurance.

    Product
    Polyhexamethylene biguanide 2% stock solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide