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.

651–663 of 663

  • SevereFDA (Drugs)·D-1137-2014·2014-03-12

    Testosterone Cypionate Recalled for Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all unexpired lots of Testosterone Cypionate 100mg/ml due to quality control issues affecting sterility.

    Product
    Testosterone Cypionate 100mg/ml
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1103-2014·2014-03-12

    Cyanocobalamin Injection Recalled for Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all lots of Cyanocobalamin 100mcg/ml injection due to quality control issues affecting sterility assurance.

    Product
    Cyanocobalamin 100mcg/ml injection
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0434-2014·2013-12-11

    Advanced Sterilization Products Recalls SteriTite Containers Due to Sterility Assurance Concerns

    Advanced Sterilization Products is recalling SteriTite containers because data does not consistently show that the required sterility assurance level is achieved during testing.

    Product
    STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-867-2013·2013-08-21

    Pallimed Solutions Recalls DMSO Aqueous Irrigation 50% Due to Sterility Concerns

    Pallimed Solutions is recalling DMSO Aqueous Irrigation 50% because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.

    Product
    DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-821-2013·2013-07-31

    Gilead Recalls AmBisome Injection Due to Potential Sterility Assurance Issues

    Gilead Sciences is recalling 478,352 vials of AmBisome (amphotericin B) liposome for Injection due to a lack of sterility assurance detected during routine manufacturing simulations.

    Product
    AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, 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
    0 states
  • HighFDA (Drugs)·D-123-2013·2013-01-09

    Saline 10% and 3% vials are recalled for sterility assurance concern

    New England Compounding Center is recalling 54 vials of Saline 10% and 3% in 5 mL and 10 mL sizes because sterility could not be assured. The vials were distributed nationwide, and all lot codes are included.

    Product
    Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide