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.

976–1000 of 1417

  • 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-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-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-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-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-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-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-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-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 23%/
    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-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-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-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-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-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-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-0260-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Glutathione Vials Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 367 vials of compounded Glutathione 200 mg/mL nationwide because the products lack assurance of sterility.

    Product
    Glutathione 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0310-2017·2017-01-11

    Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling TriMix compounded injections because the products may not be sterile. The recall covers vials compounded between May and November 2016.

    Product
    TriMix, Alprostadil/Phentolamine/Papaverine 10mcg/0.5mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0291-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Sermorelin Forte Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 188 vials of Sermorelin Forte 12 mg because the agency could not ensure the sterile products were free from contamination.

    Product
    Sermorelin Forte 12 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg). Compounded by Tri-Coast Pharmacy
    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
  • SevereFDA (Drugs)·D-0384-2017·2017-01-11

    Wells Pharmacy Recalls QUAD2 Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling QUAD2 injectable vials because they may not be sterile. The recall covers vials prepared between February and September 2016.

    Product
    QUAD2 (PAP/PHEN/ALPROS/ATRO) 9 mg/1 mg/10 mg/0.1 mg/mL Injectable a) 2 mL and b) 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0308-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Tri-Amino Sterile Compounded Products

    Tri-Coast Pharmacy is recalling 78 vials of Tri-Amino sterile compounded products due to a lack of assurance of sterility.

    Product
    Tri-Amino (Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg/Lidocaine HCL 10 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0281-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Quad Mix Compounded Drug Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling Quad Mix compounded drug vials because the agency could not ensure the products were sterile.

    Product
    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/9mg/0.1mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0258-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Glucosamine Vials Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 30 vials of compounded Glucosamine 200 mg/mL because the agency cannot assure the products are sterile.

    Product
    Glucosamine 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0283-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Quad Mix Injection Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling Quad Mix injection vials because the FDA cannot assure the products are sterile. The recall covers vials compounded between May and November 2016.

    Product
    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/19mg/190mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide