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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8101–8125 of 11823

  • SevereFDA (Drugs)·D-318-2016·2015-11-25

    Essential Wellness Recalls Methylcobalamin Syringes Due to Sterility Concerns

    Essential Wellness Pharmacy is recalling Methylcobalamin 30 mg/mL prefilled syringes due to poor sterile production practices that compromise sterility assurance.

    Product
    Methylcobalamin 30 mg/mL PF Injection, 0.1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0353-2016·2015-11-25

    Downing Labs Recalls Phosphatidylcholine Injection Due to Sterility Concerns

    Downing Labs is recalling specific lots of Phosphatidylcholine/Deoxycholic Acid Injection because the company cannot assure the product's sterility.

    Product
    Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/2.5%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/4.2%, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dalla
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0376-2016·2015-11-25

    Downing Labs Recalls M.I.C Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling M.I.C Injection (Preserved) because the company cannot ensure the product is sterile. The recall affects 172 vials distributed in the US and internationally.

    Product
    M.I.C Injection (Preserved), 25/50/25mg/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-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-329-2016·2015-11-25

    Essential Wellness Pharma Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling Testosterone Cypionate 200 mcg/mL injections because poor sterile production practices resulted in a lack of sterility assurance.

    Product
    Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0350-2016·2015-11-25

    Downing Labs Recalls Magnesium Sulfate Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 320 vials of Magnesium Sulfate 50% Injectable because the company cannot assure the sterility of the product.

    Product
    Magnesium Sulfate 50% Injectable, 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-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-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-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-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-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-0243-2016·2015-11-25

    US Compounding Recalls Brompheniramine Maleate Vials Due to Sterility Concerns

    US Compounding Inc is recalling 589 vials of Brompheniramine Maleate due to deficient practices that may impact sterility assurance.

    Product
    Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3019-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0377-2016·2015-11-25

    Downing Labs Recalls Zinc Sulfate Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 74 vials of Zinc Sulfate Injection due to a lack of assurance of sterility. The product was distributed nationwide and internationally.

    Product
    Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL 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-311-2016·2015-11-25

    Essential Wellness Pharma Recalls HCG Injections Due to Sterility Concerns

    Kalman Health & Wellness is recalling HCG 10,000 Units/mL injections because poor sterile production practices created a lack of sterility assurance.

    Product
    HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) 2.0 mL, e) 2.4 mL, f) 3.6 mL, g) 4 mL, h) 4.8 mL vials; and i) 0.1 mL, j) 0. 2 mL, k) 0.3 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    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-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-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-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-323-2016·2015-11-25

    Essential Wellness Pharma Recalls QUAD MIX Injection Due to Sterility Concerns

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

    Product
    QUAD MIX (30 mg-1 mg-20 mcg-0.16 mg / mL) Injection, 5.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0244-2016·2015-11-25

    US Compounding Recalls Cyclo/PE/Trop PF Eye Drops for Sterility Concerns

    US Compounding Inc is recalling 135 bottles of Cyclo/PE/Trop PF eye drops nationwide due to deficient practices that may impact sterility assurance.

    Product
    Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3049-03
    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-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-316-2016·2015-11-25

    Essential Wellness Recalls Methylcobalamin Syringes Due to Sterility Concerns

    Essential Wellness Pharmacy is recalling Methylcobalamin 20 mg/mL prefilled syringes due to poor sterile production practices that compromised sterility assurance.

    Product
    Methylcobalamin 20 mg/mL PF Injection, 0.05 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    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-0351-2016·2015-11-25

    Downing Labs Recalls Cyanocobalamin Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling Cyanocobalamin Buffered Injectable 3mg/mL vials because the company cannot ensure the product is sterile.

    Product
    Cyanocobalamin Buffered Injectable 3mg/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