The Recall Desk

Hazard

Sterility Deficiency recalls

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

What the numbers show

Total
8
Critical
0
Severe
4
Most recent
2026-05-13

Of the 8 sterility deficiency recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (50%) 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 deficiency 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.

1–8 of 8

  • SevereFDA (Drugs)·D-0519-2026·2026-05-13

    Octreotide Acetate Injectable Suspension Recalled Due to Sterility Assurance

    Teva Pharmaceuticals USA, Inc. is recalling 2,200 kits of Octreotide Acetate for Injectable Suspension (30 mg) due to quality system deficiencies that affect sterility assurance. The recall affects all lots nationwide.

    Product
    OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1031-2023·2023-08-09

    Cardioplegia Solution Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling Cardioplegia Solution (100 mEq K) due to inadequate validation of decontamination processes. The recall affects 284 units distributed nationwide. Affected facilities should discontinue use and contact the manufacturer.

    Product
    CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High Potassium / Low dextrose, IV Bag, total volume = 500 mL, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0107-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0053-2023·2022-11-09

    Semaglutide Injection Recalled Due to Sterility Assurance Deficiency

    The FDA is recalling semaglutide injection from Vital Care Compounder for lack of assurance of sterility. The recall affects specific lots distributed in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0048-2022·2021-11-03

    Compounded Anabolic Steroid Product Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling a compounded anabolic steroid product due to FDA concerns about sterility assurance identified during inspection. The product was distributed to approximately 494 patients in seven states.

    Product
    TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0059-2022·2021-11-03

    Methylcobalamin Injectable: Sterility Assurance Deficiency

    Red Mountain Compounding Pharmacy is recalling methylcobalamin 1000 mcg/mL injectable due to FDA inspection findings that raised concerns about the product's sterility assurance.

    Product
    METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Devices)·Z-0764-2017·2016-12-21

    Teleflex Visistat Skin Staplers Recalled for Sterility Deficiency

    Teleflex Medical is recalling Visistat 35W disposable skin staplers because improper packaging seals mean sterility is not assured.

    Product
    WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2751-2016·2016-09-14

    Biomet Microfixation Recalls Hard Tissue Replacement Implants Due to Sterility Deficiency

    Biomet Microfixation is recalling 54 custom-made Hard Tissue Replacement implants due to a potential sterility deficiency. The affected units were distributed in the US and internationally.

    Product
    Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0311-2015·2014-12-31

    Vann Healthcare Recalls Lidocaine Syringes Due to Sterility Concerns

    Vann Healthcare Services is recalling Lidocaine 4% syringes because an FDA inspection found deficiencies in the facility's ability to assure sterility.

    Product
    Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
    Category
    Drug
    Distribution
    1 state