The Recall Desk

Hazard

Sterility recalls

2,383 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,383
Critical
1
Severe
2,113
Most recent
2026-08-26

Of the 2,383 sterility recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,113 (89%) 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 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.

876–900 of 2383

  • SevereFDA (Drugs)·D-0710-2017·2017-05-24

    Key Pharmacy Recalls 5-MTHF Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 5-MTHF SDV 5mg/mL injections because the firm cannot assure the sterility of the compounded drugs.

    Product
    5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0770-2017·2017-05-24

    Key Pharmacy Recalls Methyl-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 25 vials of Methyl-B12 injection due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.

    Product
    METHYL-B12 *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0731-2017·2017-05-24

    Key Pharmacy Recalls PGE1 Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling PGE1 MDV 20mcg/mL injections due to a lack of assurance of sterility. The affected products were distributed in the U.S., Australia, and Canada.

    Product
    PGE1 MDV 20MCG/ML INJ, Injection, 20mcg/mL, Rx only, packaged in a 5 mL, 10mL, and 15 mL Glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0776-2017·2017-05-24

    Key Pharmacy Recalls Pyridoxal-5-Phosphate Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling Pyridoxal-5-Phosphate 100mg/mL injections due to a lack of assurance of sterility.

    Product
    PYRIDOXAL-5-PHOS 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0708-2017·2017-05-24

    Key Pharmacy Recalls 5-MTHF Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 5-MTHF 10mL multiple-dose vials due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.

    Product
    5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0738-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Drug Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX 10/30/1 injection due to a lack of assurance of sterility.

    Product
    TRI MIX 10/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/30mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0772-2017·2017-05-24

    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 ensure the products are sterile.

    Product
    PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0757-2017·2017-05-24

    Key Pharmacy Recalls PGE1/Procaine Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of PGE1/Procaine injection because the firm cannot ensure the sterile compounded drugs are free from contamination.

    Product
    PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0734-2017·2017-05-24

    Key Pharmacy Recalls Compounded PGE1/PAP Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of compounded PGE1/PAP injection because the firm cannot assure the sterility of the product.

    Product
    PGE1/PAP 10/30 5ML MDV MCG/MG/ML INJ, Injection, 10mg/30mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0681-2017·2017-05-03

    Isomeric Pharmacy Recalls Methylprednisolone Acetate Injection Vials for Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 4,001 vials of Methylprednisolone Acetate and Lidocaine HCl injection due to production processes that cannot assure sterility.

    Product
    Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0685-2017·2017-05-03

    Isomeric Pharmacy Recalls Injection Vials Due to Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 851 vials of a multi-dose injection product because production processes cannot assure sterility.

    Product
    Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0686-2017·2017-05-03

    Isomeric Pharmacy Recalls Testosterone Injection Vials Due to Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 2,156 vials of Testosterone Cypionate and Propionate injection due to production processes that cannot assure sterility.

    Product
    Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0661-2017·2017-04-19

    Akorn Recalls Latanoprost Ophthalmic Solution Due to Sterility Assurance Issues

    Akorn, Inc. is recalling Latanoprost Ophthalmic Solution, 0.005%, because bottles were found empty, under-filled, or leaking, compromising sterility.

    Product
    LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0571-2017·2017-03-22

    Synergy Rx Supreme Bleaching Cream Recalled for Sterility Assurance Issues

    Synergy Rx is recalling Supreme Bleaching Cream due to a lack of assurance of sterility and CGMP deviations.

    Product
    SUPREME BLEACHING CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arbutin OTC 2%, Azeliac acid OTC 2%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0526-2017·2017-03-22

    Synergy Rx Recalls Tacrolimus Ointment Due to Sterility Concerns

    Synergy Rx is recalling all lots of Tacrolimus 0.1% Ointment and Tacrolimus 0.1%/Ketoconazole 2% due to lack of assurance of sterility and CGMP deviations.

    Product
    TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%, Rx only, Synergy Rx, 4901 Morena Blvd #504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0565-2017·2017-03-22

    Synergy Rx Recalls LTP Ophthalmic Solution Due to Sterility Concerns

    Synergy Rx is recalling LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%) ophthalmic solution nationwide due to lack of assurance of sterility and CGMP deviations.

    Product
    LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0556-2017·2017-03-22

    Synergy Rx Recalls DUO Cream Due to Sterility Assurance Concerns

    Synergy Rx is recalling DUO Cream because the product lacks assurance of sterility and has CGMP deviations. The recall covers all lots distributed nationwide.

    Product
    DUO Cream (Retinoic Acid 0.05%, Hydroquinone 6%, Kojic Acid 3%, Hydrocortisone 0.1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0530-2017·2017-03-22

    Synergy Rx Recalls Topical Gels and Creams Due to Sterility Concerns

    Synergy Rx is recalling specific prescription topical gels and creams because they may lack assurance of sterility and have CGMP deviations.

    Product
    ADAPALENE 0.1%, BENZOYL PEROXIDE 2.5% GEL, ADAPELENE 0.3%, BENZOYL PEROXIDE 2,5% GEL, AZELAIC ACID 15% CREAM, AZELAIC ACID 20% IN OI FREE 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-0536-2017·2017-03-22

    Synergy Rx Recalls Erythromycin Cream Due to Sterility Assurance Issues

    Synergy Rx is recalling Erythromycin 2% in CeraVe Cream and Erythromycin 3% / Retinoic Acid 0.05% due to lack of assurance of sterility and CGMP deviations.

    Product
    ERYTHROMYCIN 2% IN CERAVE CREAM, ERYTHROMYCIN 3% / RETINOIC ACID 0.05%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0527-2017·2017-03-22

    Synergy Rx Recalls Fluorouracil Creams Due to Sterility Assurance Issues

    Synergy Rx is recalling Fluorouracil creams due to a lack of assurance of sterility and CGMP deviations.

    Product
    5-FLUOROURACIL IN VANICREAM, FLUOROURACIL in all strengths including 0.05%, 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CREAM, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0591-2017·2017-03-22

    Synergy Rx Recalls Purified Water Due to Sterility Assurance Concerns

    Synergy Rx is recalling all lots of Purified Water due to a lack of assurance of sterility and CGMP deviations.

    Product
    PURIFIED WATER, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0551-2017·2017-03-22

    Synergy Rx Brightening Cream Recalled for Sterility Assurance Issues

    Synergy Rx is recalling Brightening Cream due to a lack of assurance of sterility and CGMP deviations. The product is distributed nationwide.

    Product
    BRIGHTENING CREAM (Retinoic acid 0.1%, Hydroquinone 4%, 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-0522-2017·2017-03-22

    Synergy Rx Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Synergy Rx is recalling 1,809 vials of Human Chorionic Gonadotropin (HCG) because the product lacks assurance of sterility and has CGMP deviations.

    Product
    Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0559-2017·2017-03-22

    Synergy Rx Recalls Gentle Bleaching Cream Due to Sterility Concerns

    Synergy Rx is recalling Gentle Bleaching Cream because the product lacks assurance of sterility and has CGMP deviations.

    Product
    GENTLE BLEACHING CREAM (Retinoic Acid 0.025, 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-0533-2017·2017-03-22

    Synergy Rx Bleaching Cream Recalled for Sterility Assurance Issues

    Synergy Rx is recalling Bleaching Cream products due to a lack of assurance of sterility and CGMP deviations.

    Product
    BLEACHING CREAM 0.1% CREAM, BLEACHING CREAM HQ4%, BLEACHING CREAM-NO HQ, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide