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.

1501–1525 of 1691

  • SevereFDA (Drugs)·D-868-2013·2013-08-21

    Gentamicin Sulfate Irrigation Recalled Due to Sterility Assurance Concerns

    Pallimed Solutions is recalling Gentamicin Sulfate Irrigation nationwide because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.

    Product
    Gentamicin Sulfate Irrigation, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-864-2013·2013-08-21

    Pallimed Recalls Compounded Cyclosporine Ophthalmic Due to Sterility Concerns

    Pallimed Solutions is recalling compounded Cyclosporine Ophthalmic because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-876-2013·2013-08-21

    Pallimed Solutions Recalls Testosterone Injections Due to Sterility Concerns

    Pallimed Solutions is recalling Testosterone Cypionate/Enanthate injections nationwide due to FDA inspectional findings regarding sterility assurance and quality control.

    Product
    Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-870-2013·2013-08-21

    Pallimed Solutions Recalls Hydroxyprogesterone Compounded Due to Sterility Concerns

    Pallimed Solutions is recalling compounded Hydroxyprogesterone CAPR. (G.S.) due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    Hydroxyprogesterone CAPR.(G.S.), compounded by Pallimed Solutions Pharmacy, Woburn MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-872-2013·2013-08-21

    Pallimed Solutions Recalls MIC with B6 and B12 Due to Sterility Concerns

    Pallimed Solutions is recalling MIC with B6 and B12 vials because FDA inspectional findings raised concerns about quality control procedures and sterility assurance.

    Product
    MIC with B6 and B12, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-866-2013·2013-08-21

    Pallimed Solutions Recalls Dexamethasone PF Due to Sterility Concerns

    Pallimed Solutions is recalling Dexamethasone PF compounded in Woburn, MA, due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    Dexamethasone PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-871-2013·2013-08-21

    Pallimed Methylcobalamin Recall Due to Sterility Assurance Concerns

    Pallimed Solutions is recalling Methylcobalamin PF vials nationwide due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    Methylcobalamin PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-858-2013·2013-08-21

    Pallimed Recalls Alprostadil Injection Due to Sterility Assurance Concerns

    Pallimed Solutions is recalling 408 vials of Alprostadil IN NS Injection nationwide because FDA inspectional findings raised concerns about sterility assurance.

    Product
    Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-859-2013·2013-08-21

    Pallimed Solutions Recalls Atropine Injection Due to Sterility Concerns

    Pallimed Solutions is recalling Atropine Injection compounded in Woburn, MA, due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    Atropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-852-2013·2013-08-14

    Apotex Recalls Latanoprost Ophthalmic Solution Due to Sterility Concerns

    Apotex Inc. is recalling Latanoprost Ophthalmic Solution, 0.005%, because it failed a preservative effectiveness test, raising concerns about potential microbial growth.

    Product
    Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L 1T9; Manufactured for: Apotex Corp., Weston, FL 33326; NDC 60505-0565-1; UPC 3 60505 05651 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1891-2013·2013-08-14

    ASO Recalls HEB Wound Closure Adhesive Surgical Tape Strips Due to Sterility Concerns

    ASO, LLC is recalling HEB Wound Closure Adhesive Surgical Tape Strips because the manufacturer cannot confirm the product's sterility.

    Product
    HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, close and support small cuts and wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1888-2013·2013-08-14

    CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips Recalled for Sterility Concerns

    ASO, LLC is recalling CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips because the manufacturer cannot confirm the product's sterility.

    Product
    CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1892-2013·2013-08-14

    ASO Leader Wound Closure Adhesive Surgical Tape Strips Recalled for Sterility Concerns

    ASO, LLC is recalling Leader Wound Closure Adhesive Surgical Tape Strips because the company cannot confirm the products are sterile.

    Product
    Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 096295114706 Used to secure, close and support small cuts and wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1889-2013·2013-08-14

    ASO Recalls Wound Closure Tape Strips Due to Sterility Concerns

    ASO, LLC is recalling Discount Drug Mart wound closure adhesive tape strips because the company cannot confirm the product is sterile.

    Product
    Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 093351120374 Used to secure, close and support small cuts and wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1894-2013·2013-08-14

    ASO Recalls Premier Value Wound Closure Adhesive Tape Due to Sterility Concerns

    ASO, LLC is recalling Premier Value Wound Closure Adhesive Surgical Tape Strips because the manufacturer could not confirm the product's sterility.

    Product
    Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 040986021558 Used to secure, close and support small cuts and wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-811-2013·2013-07-31

    Med Prep Consulting Recalls Compounded Products Due to Sterility Concerns

    Med Prep Consulting, Inc. is recalling all compounded products due to a lack of assurance of sterility and potential mold contamination.

    Product
    All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-820-2013·2013-07-31

    Astellas Recalls AmBisome Injection Lots Due to Sterility Concerns

    Astellas Pharma US is voluntarily recalling specific lots of AmBisome (amphotericin B) liposome for injection because a routine simulation detected bacterial contamination.

    Product
    AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc, San Dimas, CA 91773, NDC: 0469-3051-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-819-2013·2013-07-31

    Alkermes Recalls VIVITROL Vials Due to Sterility Assurance Concerns

    Alkermes, Inc. is recalling 3,325 vials of VIVITROL (naltrexone) because the product failed container closure integrity testing, raising concerns about sterility.

    Product
    VIVITROL — VIVITROL (NALTREXONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-722-2013·2013-07-17

    Olympia Pharmacy Recalls Diclazuril Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Diclazuril 10 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Diclazuril 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-766-2013·2013-07-17

    Olympia Pharmacy Recalls PEN-DEX-CHLOR Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling PEN-DEX-CHLOR Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

    Product
    PEN-DEX-CHLOR Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-718-2013·2013-07-17

    Olympia Pharmacy Recalls Detomidine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Detomidine w/Xylazine Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Detomidine w/Xylazine 100 mg/mg Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-753-2013·2013-07-17

    Olympia Pharmacy Recalls Metabolase Forte Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Metabolase Forte Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Metabolase Forte Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-706-2013·2013-07-17

    Olympia Pharmacy Recalls Bi Mix Due to Sterility Concerns

    Olympia Pharmacy is recalling Bi Mix compounded in Orlando, FL, due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Bi mix, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-698-2013·2013-07-17

    Aminocaproic Acid Injection Recalled for Sterility Concerns

    Olympia Pharmacy is recalling Aminocaproic Acid 250 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Aminocaproic Acid 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide