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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8201–8225 of 11856

  • SevereFDA (Drugs)·D-0238-2016·2015-11-25

    US Compounding Recalls Betamethasone Vials Due to Sterility Concerns

    US Compounding Inc is recalling 19,494 vials of Betamethasone Combo 10 mL due to deficient practices that may impact sterility assurance.

    Product
    Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-10
    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-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-313-2016·2015-11-25

    Essential Wellness Pharma Recalls LIPO-B Special Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling LIPO-B Special Injection vials because poor sterile production practices created a lack of sterility assurance.

    Product
    LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-332-2016·2015-11-25

    Essential Wellness Pharma Recalls TRIMIX #1 Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling TRIMIX #1 Injection vials because poor production practices may have compromised the sterility of the compounded sterile preparations.

    Product
    TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0381-2016·2015-11-25

    Downing Labs Recalls Magnesium Sulfate Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 304 vials of Magnesium Sulfate Injection because the product lacks assurance of sterility. The affected vials were distributed nationwide and internationally.

    Product
    Magnesium Sulfate Injection (4060mOsm/L), 50%, 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-0355-2016·2015-11-25

    Downing Labs Recalls HCG Injectable Due to Sterility Assurance Concerns

    Downing Labs, LLC is recalling 1,062 vials of HCG (Lyophilized) Injectable because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.

    Product
    HCG (Lyophilized) Injectable, 5000 units/vial, 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-319-2016·2015-11-25

    Essential Wellness Pharma Recalls MIC Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling MIC Injection vials because poor production practices may have compromised the sterility of the finished drugs.

    Product
    MIC Injection, 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0289-2016·2015-11-25

    US Compounding Recalls Tropicamide and Phenylephrine Eye Drops for Sterility Concerns

    US Compounding Inc is recalling 1,833 bottles of Tropicamide 0.5%/Phenylephrine 5% eye drops nationwide due to deficient practices that may impact sterility assurance.

    Product
    Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3298-02
    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-322-2016·2015-11-25

    Essential Wellness Pharma Recalls Progesterone Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling specific lots of Progesterone 100 mg/mL Ethyl Oleate Injection due to poor sterile production practices that compromise sterility assurance.

    Product
    Progesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    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-331-2016·2015-11-25

    Essential Wellness Pharma Recalls Testosterone Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling Testosterone CYP/ENAN/PROP Injection vials due to poor sterile production practices that compromise sterility assurance.

    Product
    Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 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-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-0362-2016·2015-11-25

    Downing Labs Recalls TNPDR Injection Buffered Due to Sterility Concerns

    Downing Labs, LLC is recalling 481 vials of TNPDR Injection Buffered because the company cannot ensure the product is sterile. The recall covers all lots distributed nationwide and internationally.

    Product
    TNPDR Injection Buffered, 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-0361-2016·2015-11-25

    Downing Labs Recalls Green Tea Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling Green Tea (EGCG) Injectable vials because the company cannot ensure the product is sterile. The recall covers 23 vials distributed in the US and internationally.

    Product
    Green Tea (EGCG) Injectable, 10mg/mL,10mL 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-0247-2016·2015-11-25

    US Compounding Recalls Dapiprazole Ophthalmic Vials Due to Sterility Concerns

    US Compounding Inc is recalling 2,984 bottles of compounded Dapiprazole ophthalmic vials nationwide due to deficient practices that may impact sterility assurance.

    Product
    Dapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0201-99
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0278-2016·2015-11-25

    US Compounding Recalls Pilocarpine Ophthalmic Drops Due to Sterility Concerns

    US Compounding Inc is recalling specific lots of Pilocarpine (1/16%) Ophthalmic drops because deficient practices may have impacted sterility assurance.

    Product
    Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653
    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-0251-2016·2015-11-25

    US Compounding Recalls ePHEDrine Sulfate Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 12,191 syringes of ePHEDrine Sulfate PF (50 mg/10 mL) nationwide due to deficient practices that may impact sterility assurance.

    Product
    ePHEDrine Sulfate PF (50 mg/10 mL), 10 mL Single-Use Syringe, For IV or IM Use Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3084-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0270-2016·2015-11-25

    US Compounding Recalls Morphine PF Vials Due to Sterility Concerns

    US Compounding Inc is recalling 5,919 vials of Morphine PF due to deficient practices that may impact sterility assurance.

    Product
    Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2171-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-317-2016·2015-11-25

    Essential Wellness Recalls Methylcobalamin Syringes Due to Sterility Concerns

    Essential Wellness Pharmacy is recalling Methylcobalamin 25 mg/mL prefilled syringes due to poor sterile production practices that compromise sterility assurance.

    Product
    Methylcobalamin 25 mg/mL PF Injection, 0.5 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-303-2016·2015-11-25

    Essential Wellness Pharma Recalls Dexamethasone Ointment Due to Sterility Concerns

    Essential Wellness Pharma is recalling Dexamethasone 0.4% Opth Ointment because poor production practices may have compromised sterility.

    Product
    Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-326-2016·2015-11-25

    Essential Wellness Pharma Recalls Sermorelin Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling Sermorelin 1000 mcg/mL / LIDO 0.2% Injection vials because poor sterile production practices resulted in a lack of sterility assurance.

    Product
    sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0284-2016·2015-11-25

    US Compounding Recalls Triamcinolone Acetonide Vials Due to Sterility Concerns

    US Compounding Inc is recalling 1,244 vials of compounded Triamcinolone acetonide due to deficient practices that may impact sterility assurance.

    Product
    Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3203-07
    Category
    Drug
    Distribution
    Distributed nationwide