The Recall Desk

Hazard

Lack Of Sterility recalls

1,423 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,423
Critical
3
Severe
1,055
Most recent
2026-10-14

Of the 1,423 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 1,055 (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.

976–1000 of 1423

  • SevereFDA (Drugs)·D-0955-2017·2017-07-19

    Advanced Pharma Recalls Potassium Phosphate Bags Due to Sterility Concerns

    Advanced Pharma Inc. is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride bags because the company cannot assure the product's sterility.

    Product
    Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-924-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2531-2017·2017-06-21

    Boston Scientific Steerable Sheath Recalled for Lack of Sterility Assurance

    Creganna Medical Devices is recalling 100 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 M004EPTMCA85400
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2530-2017·2017-06-21

    Boston Scientific Steerable Sheath Recalled for Lack of Sterility Assurance

    Creganna Medical Devices is recalling 150 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance. The devices were distributed in Massachusetts.

    Product
    Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0745-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Drug Vials Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 17 vials of TRI MIX 20/30/2 injection due to a lack of assurance of sterility.

    Product
    TRI MIX 20/30/2 5ML MDV MCG/MG/MG/1ML INJ, Injection, 20mcg/30mg/2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial , Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0724-2017·2017-05-24

    Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot ensure the products are sterile.

    Product
    HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 30ML PBF MDV 5MG/ML INJ, 5mg/mL, RX only, 30 mL Glass/ Multiple Dose vial.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0758-2017·2017-05-24

    Key Pharmacy Recalls Alpha Lipoic Acid Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling Alpha Lipoic Acid injections due to a lack of assurance of sterility. The affected product was distributed in the U.S., Australia, and Canada.

    Product
    ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injection, 25mg/mL, Rx only, 25 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0715-2017·2017-05-24

    Key Pharmacy Recalls DMSO 6.25% Ophthalmic Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling DMSO 6.25% Ophthalmic Solution because the firm cannot ensure the product is sterile.

    Product
    DMSO 6.25% OPHTH., 6.25%, Rx only, 15 mL plastic/Multiple Dose bottle, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0774-2017·2017-05-24

    Key Pharmacy Recalls Procaine HCL Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Procaine HCL 2% injections because the firm cannot guarantee the products are sterile.

    Product
    PROCAINE HCL SDV 2% INJ, Injection, 2%, Rx only, packaged in 10mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0771-2017·2017-05-24

    Key Pharmacy Recalls Procaine HCL Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Procaine HCL 1% injections because the firm cannot assure the products are sterile.

    Product
    PROCAINE HCL 50ML MDV (CALIF) 1% INJ, Injection, 1%, Rx only, 50mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0736-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 10/15/2.5 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.

    Product
    TRI MIX 10/15/2.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/2.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0779-2017·2017-05-24

    Key Pharmacy Recalls Sodium Carboxymethylcellulose Ophthalmic Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Sodium Carboxymethylcellulose 0.5% Ophthalmic Solution because the firm cannot ensure the product is sterile.

    Product
    SODIUM CARBOXYM-CELL PF 0.5% OPHTH, opthalmic, 0.50%, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0760-2017·2017-05-24

    FDA Recalls Compounded Injection Due to Lack of Sterility Assurance

    Key Pharmacy and Compounding Center is recalling CHOL/IN/ME(L)/B6 10ML MDV injection due to lack of assurance of sterility.

    Product
    CHOL/IN/ME(L)/B6 10ML MDV 50/50/25/0.1MG/ML INJ, Injection, 50mg/50mg/25mg/0.1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0602-2017·2017-03-22

    Synergy Rx Recalls Kojic Acid and Azelaic Acid Cream Due to Sterility Concerns

    Synergy Rx is recalling Kojic Acid 8%/Azelaic Acid 15% Cream because it lacks assurance of sterility and has CGMP deviations.

    Product
    KOJIC ACID 8%/AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0593-2017·2017-03-22

    Synergy Rx Recalls Lidocaine Creams Due to Sterility Assurance Issues

    Synergy Rx is recalling various lidocaine cream and ointment products nationwide due to a lack of assurance of sterility and CGMP deviations.

    Product
    LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% CREAM, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% OINTMENT LIDOCAINE 23%/ TETRACAINE 7% CREAM, LIDOCAINE 23%/TETRACAINE 7% OINTMENT, LIDOCAINE…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0581-2017·2017-03-22

    Synergy Rx Recalls Betamethasone 0.25% Due to Sterility Assurance Issues

    Synergy Rx is recalling Betamethasone 0.25% cream because it may not be sterile. The recall covers all lots distributed nationwide.

    Product
    BETAMETHASONE 0.25%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0573-2017·2017-03-22

    Synergy Rx Recalls TCA Peel Solutions Due to Sterility Concerns

    Synergy Rx is recalling TCA Peel Solutions in all strengths due to a lack of assurance of sterility and CGMP deviations.

    Product
    TCA PEEL SOLUTION in all strengths including: 5%, 10%, 15%, 18%, and 20%, TCA 10%/LACTIC ACID 12%, TCA 6%/ LACTIC ACID12%, TCA 7%/SALICYLIC ACID 2% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0598-2017·2017-03-22

    Sulfur 5% Cream Recalled for Lack of Sterility Assurance

    Synergy Rx is recalling Sulfur 5% Cream due to a lack of assurance of sterility and CGMP deviations.

    Product
    SULFUR 5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0580-2017·2017-03-22

    Synergy Rx Recalls Diclofenac Lip Balm Due to Sterility Concerns

    Synergy Rx is recalling Diclofenac Lip Balm products because they may not be sterile. The recall covers all lots distributed nationwide.

    Product
    DICLOFENAC 3% and 5% LIP BALM and DICLOFENAC 5% SPF 30 LIP BALM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0564-2017·2017-03-22

    Synergy Rx Recalls Malek's Magic Plus Due to Sterility Concerns

    Synergy Rx is recalling Malek's Magic Plus prescription cream because it lacks assurance of sterility and has CGMP deviations.

    Product
    MALEK'S MAGIC PLUS (retinoic acid 0.1%, hydroquinone 6%, kojic acid 3%, hydrocortisone 1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0499-2017·2017-03-08

    United Exchange Recalls Eye Wash Bottles Due to Sterility Concerns

    United Exchange Corporation is recalling 190,710 bottles of Eye Wash due to a lack of assurance of sterility. The product was distributed nationwide, in Puerto Rico, and in Guyana.

    Product
    EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0498-2017·2017-03-08

    United Exchange Eye Wash Recalled Due to Lack of Sterility Assurance

    United Exchange Corporation is recalling 77,184 bottles of Eye Wash because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide, in Puerto Rico, and in Guyana.

    Product
    Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp., 17211 Valley View Ave., Cerritos, CA 90703, Made in Korea, UPC Code: 780707005828
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0480-2017·2017-03-01

    Hospira Recalls Metronidazole Injection Bags Due to Leaking

    Hospira is recalling 578,784 bags of Metronidazole Injection due to a customer report of a leaking bag, which compromises sterility assurance.

    Product
    METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0366-2017·2017-01-11

    Wells Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 265 vials of compounded Methylcobalamin 5,000 mcg/mL Injectable because the product lacks assurance of sterility.

    Product
    Methylcobalamin 5,000 mcg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0268-2017·2017-01-11

    Tri-Coast Pharmacy Recalls L-Tyrosine Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 50 vials of compounded L-Tyrosine 10 mg/mL because the products lack assurance of sterility.

    Product
    L-Tyrosine 10 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide