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 11823

  • SevereFDA (Drugs)·D-308-2016·2015-11-25

    FDA Recalls HCG Injection Vials Due to Sterility Concerns

    FDA is recalling HCG 2000 Units/mL Injection vials from Essential Wellness Pharmacy due to poor sterile production practices.

    Product
    HCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-310-2016·2015-11-25

    Essential Wellness Recalls HCG Injection Vials Due to Sterility Concerns

    Essential Wellness Pharmacy is recalling HCG 5000 Units/mL injection vials because poor production practices raised concerns about the sterility of the compounded drugs.

    Product
    HCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    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-0342-2016·2015-11-25

    Downing Labs Recalls Ascorbic Acid Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling Ascorbic Acid Injectable 500mg/mL vials due to a lack of assurance of sterility. The recall affects 4,857 vials distributed in the US and 17 other countries.

    Product
    Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL vials, 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-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-0264-2016·2015-11-25

    US Compounding Recalls Methylcobalamin Vials Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 265 vials of Methylcobalamin injection due to deficient practices that may impact sterility assurance.

    Product
    Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3251-04.
    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-0374-2016·2015-11-25

    Downing Labs Recalls DMAE Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling DMAE Dimethylaminoethanol Injection due to a lack of assurance of sterility. The recall affects 16 vials distributed nationwide and internationally.

    Product
    DMAE Dimethylaminoethanol Injection, 100mg/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-0258-2016·2015-11-25

    US Compounding Recalls Hyaluronidase PF Vials Due to Sterility Concerns

    US Compounding Inc is recalling 1,096 vials of Hyaluronidase PF (150 units/mL) nationwide due to deficient practices that may impact sterility assurance.

    Product
    Hyaluronidase PF (150 units/mL) in 1 mL Single-Use Vial, Not for IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-312-2016·2015-11-25

    Essential Wellness Pharma Recalls LIPO B Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling 76 vials of LIPO B Injection because poor production practices created a lack of sterility assurance.

    Product
    LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0242-2016·2015-11-25

    US Compounding Recalls Bi-Mix Vials Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 96 vials of Bi-Mix sterile preparations nationwide due to deficient practices that may impact sterility assurance.

    Product
    Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3254-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0287-2016·2015-11-25

    US Compounding Recalls Triamcinolone Diacetate Vials Due to Sterility Concerns

    US Compounding Inc is recalling 33,778 vials of Triamcinolone diacetate USP PF (40 mg/mL) nationwide due to deficient practices that may impact sterility assurance.

    Product
    Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3206-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-299-2016·2015-11-25

    Essential Wellness Pharma Recalls 17-Alpha Hydroxyprogesterone Injections for Sterility Concerns

    Essential Wellness Pharma is recalling 17-Alpha Hydroxyprogesterone injections due to poor sterile production practices that compromised sterility assurance.

    Product
    17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-336-2016·2015-11-25

    Essential Wellness Pharma Recalls TRIMIX SPECIAL Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling TRIMIX SPECIAL Injection vials because poor sterile production practices created a lack of sterility assurance for the finished drugs.

    Product
    TRIMIX SPECIAL (30 mg-1 mg-10 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-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-0343-2016·2015-11-25

    Downing Labs Recalls MICML TRNDPPC Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling MICML TRNDPPC Injection (Preserved) 10mL vials because the company cannot ensure the product is sterile.

    Product
    MICML TRNDPPC Injection (Preserved) 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-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-0281-2016·2015-11-25

    US Compounding Recalls Testosterone Cypionate Vials Due to Sterility Concerns

    US Compounding Inc is recalling 2,524 vials of Testosterone cypionate, USP due to deficient practices that may impact sterility assurance.

    Product
    Testosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2131-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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-304-2016·2015-11-25

    Essential Wellness Pharma Recalls Dual Test Cyp/ena Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling Dual Test Cyp/ena Injection vials because poor sterile production practices resulted in a lack of sterility assurance.

    Product
    DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0380-2016·2015-11-25

    Downing Labs Recalls Potassium Chloride Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 225 vials of Potassium Chloride Injection due to a lack of assurance of sterility. The product was distributed nationwide and in multiple international markets.

    Product
    Potassium Chloride Injection (20mEq/10mL), 2mEq/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-305-2016·2015-11-25

    Essential Wellness Pharma Recalls Glycerin Opth Solution Due to Sterility Concerns

    Kalman Health & Wellness is recalling Glycerin Opth Solution because poor sterile production practices may have compromised the sterility of the finished drug.

    Product
    Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0239-2016·2015-11-25

    US Compounding Recalls Betamethasone Vials Due to Sterility Concerns

    US Compounding Inc is recalling 5,514 vials of Betamethasone Combo PF 2 mL due to deficient practices that may impact sterility assurance.

    Product
    Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-02
    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