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.

551–575 of 663

  • SevereFDA (Drugs)·D-0978-2017·2017-07-19

    SCA Pharmaceuticals Recalls Potassium Phosphate IV Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 20 bags of Potassium Phosphate IV solution due to a lack of sterility assurance. The affected product was distributed in LA, PA, NY, and WI.

    Product
    Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-32
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2532-2017·2017-06-21

    Boston Scientific Steerable Sheath Recalled for Sterility Assurance Issues

    Creganna Medical Devices is recalling 50 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance.

    Product
    Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1110-2017·2017-02-08

    Biom'up Recalls Renovix Collagen Membranes Due to Sterility Assurance Concerns

    Biom'up is recalling 1,682 units of Renovix Guided Healing Collagen Membranes due to a lack of sterility assurance. The products were distributed to a sole distributor in North Carolina.

    Product
    RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0386-2016·2015-12-02

    Qualgen Recalls Estradiol Pellets Due to Sterility Assurance Concerns

    Qualgen is recalling 4,221 vials of compounded Estradiol USP pellets nationwide because deficient practices may have impacted sterility assurance.

    Product
    Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01), 15 mg (NDC 69761-015-01),18 mg (NDC 69761-018-01),20 mg (NDC 69761-020-01), 22 mg (NDC 69761-022-01), 25 mg (NDC 69761-025-01), Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0249-2016·2015-11-25

    US Compounding Recalls Dex Combo Sterile Vials Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 854 vials of Dex Combo sterile injection due to deficient practices that may impact sterility assurance.

    Product
    Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 mg/mL),30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3057-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0261-2016·2015-11-25

    US Compounding Recalls Lidocaine Syringes Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 7,320 syringes of Lidocaine 1% PF for IV injection because deficient practices may have impacted sterility assurance.

    Product
    Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3099-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0264-2016·2015-11-25

    US Compounding Recalls Methylcobalamin Vials Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 265 vials of Methylcobalamin injection due to deficient practices that may impact sterility assurance.

    Product
    Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3251-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0237-2016·2015-11-25

    US Compounding Recalls Alprostadil Vials Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 82 vials of Alprostadil (PGE-1) nationwide due to deficient practices that may impact sterility assurance.

    Product
    Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC: 62295-3253-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0282-2016·2015-11-25

    US Compounding Recalls Testosterone Vials Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 1,386 vials of Testosterone EO-Pro-Cyp 220 due to deficient practices that may impact sterility assurance.

    Product
    Testosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2169-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0275-2016·2015-11-25

    US Compounding Recalls Phenylephrine Vials Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 11 vials of Phenylephrine due to deficient practices that may impact sterility assurance.

    Product
    Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, For SC, IM, IV or penile injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3289-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0258-2016·2015-11-25

    US Compounding Recalls Hyaluronidase PF Vials Due to Sterility Concerns

    US Compounding Inc is recalling 1,096 vials of Hyaluronidase PF (150 units/mL) nationwide due to deficient practices that may impact sterility assurance.

    Product
    Hyaluronidase PF (150 units/mL) in 1 mL Single-Use Vial, Not for IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0248-2016·2015-11-25

    US Compounding Recalls Dex LA 8 Vials Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 4,333 vials of Dex LA 8 (Dexamethasone acetate) nationwide because deficient practices may have impacted sterility assurance.

    Product
    Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0262-2015·2014-12-03

    Perry Drug Recalls Leuprolide Micro Lupron Kits Due to Sterility Concerns

    Perry Drug Inc. is recalling Leuprolide 50 mcg/0.1 mL Micro Lupron Kits in Kansas and Missouri due to potential sterility assurance risks identified during an FDA inspection.

    Product
    Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0273-2015·2014-12-03

    Perry Drug Recalls Tri Mix Syringes Due to Sterility Concerns

    Perry Drug Inc. is recalling Tri Mix PF SYR 0.5 mL Inj. syringes in Kansas and Missouri due to potential sterility assurance risks identified during an FDA inspection.

    Product
    Tri Mix PF SYR 0.5 mL Inj., Compounded Rx, 10 each, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5036-49
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0266-2015·2014-12-03

    Perry Drug Recalls Tri-mix Antidote Syringes Due to Sterility Concerns

    Perry Drug Inc. is recalling Tri-mix Antidote syringes in Kansas and Missouri due to potential sterility assurance issues identified during an FDA inspection.

    Product
    Tri-mix Antidote 10 each Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0205-17
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0275-2015·2014-12-03

    Perry Drug Recalls Sodium Tetradecyl Sulfate Injections Due to Sterility Concerns

    Perry Drug Inc. is recalling 20 vials of compounded Sodium Tetradecyl Sulfate 0.3% Injection in Kansas and Missouri due to potential sterility assurance issues found during an FDA inspection.

    Product
    Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-6427-90
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0261-2015·2014-12-03

    Perry Drug Recalls Tri-Mix Vials Due to Sterility Assurance Concerns

    Perry Drug Inc. is recalling 17 vials of compounded Tri-Mix in Kansas and Missouri due to quality control issues affecting sterility assurance.

    Product
    Tri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5123-09
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0260-2015·2014-12-03

    Perry Drug Recalls Methyl B12 Syringes Due to Sterility Concerns

    Perry Drug Inc. is recalling 186 prefilled syringes of Methyl B12 injection due to potential sterility assurance issues identified during an FDA inspection.

    Product
    Methyl B12 25 mg/mL Inj., 10 Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-2014-37
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0272-2015·2014-12-03

    Perry Drug Recalls HCG Vials Due to Sterility Assurance Concerns

    Perry Drug Inc. is recalling HCG-20,000 U/2 mL vials in Kansas and Missouri due to quality control issues affecting sterility assurance.

    Product
    HCG-20,000 U/2 mL Vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2195-47
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0267-2015·2014-12-03

    Perry Drug Recalls HCG Vials Due to Sterility Assurance Concerns

    Perry Drug Inc. is recalling HCG Low Dose vials in Kansas and Missouri due to quality control issues affecting sterility assurance.

    Product
    HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2596-17
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0269-2015·2014-12-03

    Perry Drug Recalls HCG Injections Due to Sterility Assurance Concerns

    Perry Drug Inc. is recalling HCG 10,000 U/10 mL PF Inj vials in Kansas and Missouri due to quality control issues affecting sterility assurance.

    Product
    HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0197-2015·2014-11-12

    Hyaluronidase Injectable Recalled Due to Sterility Assurance Concerns

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

    Product
    HYALURONIDASE, 240 u/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0173-2015·2014-11-12

    Alprostadil Injectable Recalled for Sterility Assurance Concerns

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

    Product
    ALPROSTADIL, 10 mcg/mL, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0202-2015·2014-11-12

    Recall of Injectable Methylcobalamin Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling injectable Methylcobalamin due to quality control issues affecting sterility assurance.

    Product
    METHYCOBALAMIN, preservative free, 10mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states