The Recall Desk

Hazard

Lack Of Sterility recalls

1,417 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,417
Critical
3
Severe
1,048
Most recent
2026-07-29

Of the 1,417 lack of sterility recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,048 (74%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all lack of 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.

876–900 of 1417

  • SevereFDA (Drugs)·D-1071-2018·2018-08-15

    Guardian Pharmacy Recalls Methylcobalamin Vials Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 2,000 vials of compounded Methylcobalamin 1000 mcg/mL in Texas due to a lack of sterility assurance.

    Product
    Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1063-2018·2018-08-15

    Guardian Pharmacy Recalls Fentanyl Citrate Syringes Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 300 syringes of Fentanyl Citrate 50 mcg/mL in Texas due to a lack of sterility assurance.

    Product
    Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1054-2018·2018-08-15

    Guardian Pharmacy Recalls B-Complex Due to Lack of Sterility Assurance

    Guardian Pharmacy Services is recalling B-Complex products in 100 mL bags and vials due to a lack of sterility assurance. The affected units were distributed in Texas.

    Product
    B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1065-2018·2018-08-15

    Guardian Pharmacy Recalls Ropivacaine HCl ON-Q Pumps for Sterility Concerns

    Guardian Pharmacy Services is recalling 25 units of Ropivacaine HCl 2 mg/mL 550 mL ON-Q Pumps due to a lack of sterility assurance. The products were distributed in Texas.

    Product
    Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1061-2018·2018-08-15

    Guardian Pharmacy Recalls Medroxyprogesterone Vials Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 60 vials of compounded Medroxyprogesterone 150 mg/mL in Texas due to a lack of sterility assurance.

    Product
    Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1052-2018·2018-08-15

    Guardian Pharmacy Recalls Ascorbic Acid Vials Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 4,900 vials of Ascorbic Acid 500 mg/mL in Texas due to a lack of sterility assurance.

    Product
    Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0945-2018·2018-07-25

    Avella Recalls Fentanyl Syringes Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley is recalling 100 fentanyl syringes due to potential bag leakage and lack of sterility assurance.

    Product
    fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10 mcg per mL) 5 mcg in 0.5 mL. Volume: 0.5 mL. Single dose syringe. For Cook Children's Med Ctr. By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-210-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0700-2018·2018-05-02

    Premier Pharmacy Labs Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    Premier Pharmacy Labs Inc is recalling 4,192 syringes of Morphine Sulfate 4 mg/mL PF Injection due to a lack of assurance of sterility.

    Product
    Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-127-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0648-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Naltrexone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Naltrexone 200 mg pellets because a non-approved sterilization method was used, creating a lack of assurance of sterility.

    Product
    Naltrexone 200 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0643-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Nandrolone Decanoate Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Nandrolone decanoate 200mg/mL vials because they were sterilized using a non-approved method.

    Product
    Nandrolone decanoate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0678-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Estradiol Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Estradiol 35 mg pellets in Nevada due to the use of a non-approved sterilization method.

    Product
    Estradiol 35 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0634-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Ascorbic Acid Vials Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Ascorbic Acid (Tapioca) 500 mg/mL vials because they were sterilized using a non-approved method.

    Product
    Ascorbic Acid (Tapioca) 500 mg/mL, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0682-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone/Finasteride Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone/Finasteride 80 mg/8 mg pellets because a non-approved method of sterilization was used.

    Product
    Testosterone/Finasteride 80 mg/8 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0990-2018·2018-03-21

    Alden HP59 Toric Contact Lenses Recalled for Lack of Sterility Assurance

    Alden Optical is recalling HP59 Toric Daily Wear Soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.

    Product
    Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0981-2018·2018-03-21

    Alden Optical Recalls NovaKone Daily Wear Soft Contact Lenses

    Alden Optical is recalling NovaKone Daily Wear Soft contact lenses because they lack sterility assurance. The recall covers units distributed in the US and Canada.

    Product
    NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0985-2018·2018-03-21

    Alden Optical Recalls Contact Lenses Lacking Sterility Assurance

    Alden Optical is recalling specific daily wear soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.

    Product
    Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0989-2018·2018-03-21

    Alden Classic 55 Toric Contact Lenses Recalled for Sterility Issues

    Alden Optical is recalling Alden Classic 55 Toric Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.

    Product
    Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0986-2018·2018-03-21

    Alden Optical Recalls HP59 Sphere Daily Wear Soft Contact Lenses

    Alden Optical is recalling HP59 Sphere Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.

    Product
    Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0987-2018·2018-03-21

    Alden HP49 Toric Contact Lenses Recalled for Sterility Assurance Issues

    Alden Optical is recalling 56 units of Alden HP49 Toric Daily Wear Soft contact lenses because they lack sterility assurance. The lenses were distributed in 25 US states and Canada.

    Product
    Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0983-2018·2018-03-21

    Alden Classic 38 Sphere Daily Wear Soft Contact Lenses Recalled for Sterility Issues

    Alden Optical is recalling Alden Classic 38 Sphere Daily Wear Soft contact lenses because they lack sterility assurance. The recall covers units distributed in the United States and Canada.

    Product
    Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperop
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0907-2018·2018-03-14

    Synthes Recalls Sterile Light Clip for Oracle Retractor Due to Potential Lack of Sterility

    Synthes (USA) Products LLC is recalling sterile Light Clips for the Oracle Retractor because potential gaps in the package seal may compromise sterility. The product is used during orthopedic surgery.

    Product
    Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0465-2018·2018-02-28

    Pharmedium Recalls Meperidine HCl Injections Due To Sterility Concerns

    Pharmedium Services, LLC is recalling Meperidine HCl in 0.9% Sodium Chloride injections nationwide due to a lack of sterility assurance.

    Product
    Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0466-2018·2018-02-28

    Pharmedium Recalls Methadone HCl Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Methadone HCl Injection in all strengths and packaging due to a lack of sterility assurance.

    Product
    Methadone HCl Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0445-2018·2018-02-28

    Pharmedium Recalls Phenylephrine HCl Injections Due To Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Phenylephrine HCl in 0.9% Sodium Chloride due to a lack of sterility assurance.

    Product
    Phenylephrine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide