The Recall Desk

Hazard

Sterility Assurance recalls

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

What the numbers show

Total
663
Critical
0
Severe
261
Most recent
2026-08-26

Of the 663 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 261 (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 663

  • 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-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-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-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-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-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-0194-2015·2014-11-12

    FDA Recalls Sterile Glutaraldehyde Solution Due to Quality Control Concerns

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

    Product
    GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, 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-0175-2015·2014-11-12

    Recall of Injectable Ascorbic Acid Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling injectable Ascorbic Acid (Vitamin B) due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    ASCORBIC ACID (B), 500 mg/mL, injectable, 100 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-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-0189-2015·2014-11-12

    FDA Recalls Estradiol Cypionate Injectable Due to Sterility Assurance Concerns

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

    Product
    ESTRADIOL CYPIONATE (COMPOUNDED/GRAPESEED OIL), 5 mg/mL, injectable, 1 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0216-2015·2014-11-12

    FDA Recalls Papaverine Injectable Due to Sterility Assurance Concerns

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

    Product
    PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.16mg/0.57mg/19.45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0179-2015·2014-11-12

    FDA Recalls Calcium Chloride Injectable Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling specific lots of Calcium Chloride Injectable due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0212-2015·2014-11-12

    FDA Recalls Sterile Injectable Drug Due to Quality Control Concerns

    Oregon Compounding Centers is recalling sterile injectable drug vials due to quality control issues affecting sterility assurance.

    Product
    PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0210-2015·2014-11-12

    FDA Recalls Compounded Injectable Drug Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling specific lots of a compounded injectable drug due to quality control issues affecting sterility assurance.

    Product
    PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 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-0182-2015·2014-11-12

    FDA Recalls Chorionic Gonadotropin Vials Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling 117 vials of Chorionic Gonadotropin due to quality control issues affecting sterility assurance.

    Product
    CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0192-2015·2014-11-12

    Gentamicin Sulfate Irrigation Solution Recalled for Sterility Assurance Concerns

    Creative Compounds is recalling Gentamicin Sulfate irrigation solution due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, 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-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-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-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-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
  • HighFDA (Drugs)·D-0139-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Testosterone cypionate 150 mg/mL injections due to quality control issues that may compromise sterility assurance.

    Product
    Testosterone cypionate 150 mg/mL injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide