The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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8126–8150 of 11856

  • 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-335-2016·2015-11-25

    Essential Wellness Pharma Recalls TRIMIX #4 Injection Due to Sterility Concerns

    Kalman Health & Wellness is recalling TRIMIX #4 Injection vials due to poor sterile production practices that compromise sterility assurance.

    Product
    TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-334-2016·2015-11-25

    Essential Wellness Pharma Recalls TRIMIX #3 Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling TRIMIX #3 Injection vials because poor sterile production practices resulted in a lack of sterility assurance.

    Product
    TRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0285-2016·2015-11-25

    US Compounding Recalls Triamcinolone/Lidocaine Vials Due to Sterility Concerns

    US Compounding Inc is recalling 980 vials of compounded Triamcinolone/Lidocaine due to deficient practices that may impact sterility assurance.

    Product
    Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3204-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-320-2016·2015-11-25

    Essential Wellness Pharma Recalls Compounded Progesterone Injections for Sterility Concerns

    Essential Wellness Pharma is recalling compounded progesterone injections due to poor sterile production practices that compromised sterility assurance.

    Product
    Progesterone 100 mg/mL IM* Injection in Sesame Oil, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0357-2016·2015-11-25

    Downing Labs Recalls EDTA Calcium Disodium Injectable Due to Sterility Concerns

    Downing Labs is recalling 104 vials of EDTA Calcium Disodium Injectable because the company cannot assure the product's sterility.

    Product
    EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0340-2016·2015-11-25

    Downing Labs Recalls EDTA Disodium Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling EDTA Disodium Injectable vials because the company cannot ensure the product is sterile.

    Product
    EDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0273-2016·2015-11-25

    US Compounding Recalls Phenylephrine and Lidocaine Vials Due to Sterility Concerns

    US Compounding Inc is recalling 542 vials of Phenylephrine 1.5%/Lidocaine 1% for intracameral injection due to deficient practices that may impact sterility assurance.

    Product
    Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3155-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0367-2016·2015-11-25

    Downing Labs Recalls Magnesium Chloride Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 289 vials of Magnesium Chloride Hexahydrate Injection due to a lack of assurance of sterility. The product was distributed nationwide and internationally.

    Product
    Magnesium Chloride Hexahydrate Injection 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0256-2016·2015-11-25

    US Compounding Recalls Hyaluronic Acid Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 531 hyaluronic acid and lidocaine syringes because deficient practices may have impacted sterility assurance.

    Product
    Hyaluronic Acid/Lidocaine PF (60 mg/2%), 3 mL Single Use Syringe, For Intra-Articular Injection , Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3249-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-327-2016·2015-11-25

    Essential Wellness Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Essential Wellness Pharmacy is recalling Testosterone Cypionate 50 mg/mL injections due to poor sterile production practices that compromise sterility assurance.

    Product
    Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0356-2016·2015-11-25

    Downing Labs Recalls Chromium Injectable Due to Sterility Assurance Concerns

    Downing Labs, LLC is recalling all lots of Chromium Injectable, 200mg/mL, 30mL vials because the product lacks assurance of sterility.

    Product
    Chromium Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0345-2016·2015-11-25

    Downing Labs Recalls Procaine Injectables Due to Sterility Concerns

    Downing Labs, LLC is recalling 881 vials of Procaine Injectables because the company cannot ensure the product is sterile. The affected vials were distributed in the US and 17 other countries.

    Product
    Procaine Injectables 20mg/mL and 2%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    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-0338-2016·2015-11-25

    Downing Labs Recalls L-Tyrosine Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 29 vials of L-Tyrosine Injectable because the product lacks assurance of sterility. The affected product was distributed nationwide and in multiple international markets.

    Product
    L-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0250-2016·2015-11-25

    US Compounding Recalls Dexamethasone Sodium Phosphate Vials Due to Sterility Concerns

    US Compounding Inc is recalling 235 vials of Dexamethasone Sodium Phosphate PF due to deficient practices that may impact sterility assurance.

    Product
    Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or IM Use Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3227-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0360-2016·2015-11-25

    Downing Labs Recalls Magnesium Sulfate Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 160 vials of Magnesium Sulfate Injectable because the company cannot assure the sterility of the product.

    Product
    Magnesium Sulfate Injectable, 14.28%, 7mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0359-2016·2015-11-25

    Downing Labs Recalls DMPS Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling DMPS Injectable vials because the company cannot ensure the product is sterile.

    Product
    DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0279-2016·2015-11-25

    US Compounding Recalls Prednisolone Eye Drops Due to Sterility Concerns

    US Compounding Inc is recalling Prednisolone Sodium Phosphate eye drops due to deficient practices that may impact sterility assurance.

    Product
    Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For Topical Ophthalmic Use, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0348-2016·2015-11-25

    Downing Labs Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Downing Labs is recalling Methylcobalamin Buffered Injectable vials because the company cannot guarantee the product is sterile.

    Product
    Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30mL Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0277-2016·2015-11-25

    US Compounding Recalls Phenylephrine PF Sterile Solution Due to Sterility Concerns

    US Compounding Inc is recalling Phenylephrine PF Sterile Solution (2.5%) because deficient practices may have impacted sterility assurance.

    Product
    Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3272-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0283-2016·2015-11-25

    US Compounding Recalls Trace Elements-4 IV Vials Due to Sterility Concerns

    US Compounding Inc is recalling 1,093 vials of Trace Elements-4 IV injection due to deficient practices that may impact sterility assurance.

    Product
    Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate 1.57 mg, Manganese Sulfate monohydrate USP 0.308 mg, Chromic Chloride hexahydrate USP 0.0205 mg), 10 mL Multi-Dose Vial, For IV Injection After Dilution, Dilute Before IV Use, Rx only, Compounded by
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-330-2016·2015-11-25

    Essential Wellness Pharma Recalls Testosterone Injection Vials Due to Sterility Concerns

    Kalman Health & Wellness is recalling 20 vials of Testosterone Injection due to poor sterile production practices that compromised sterility assurance.

    Product
    Testosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0364-2016·2015-11-25

    Downing Labs Recalls Sermorelin Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 287 vials of Sermorelin/GHRP-6/GHRP-2 Injection due to a lack of assurance of sterility. The product was distributed nationwide and in multiple international locations.

    Product
    Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0265-2016·2015-11-25

    US Compounding Recalls Methylprednisolone Vials Due to Sterility Concerns

    US Compounding Inc is recalling 3,629 vials of Methylprednisolone 100 mg/mL due to deficient practices that may impact sterility assurance.

    Product
    MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3115-07
    Category
    Drug
    Distribution
    Distributed nationwide