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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8176–8200 of 11856

  • 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-325-2016·2015-11-25

    Essential Wellness Pharma Recalls Sermorelin Injections Due to Sterility Concerns

    Kalman Health & Wellness is recalling Sermorelin injections due to poor sterile production practices that compromise sterility assurance.

    Product
    Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, d) 9 mL or e) 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    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-0373-2016·2015-11-25

    Downing Labs Recalls Pyridoxine Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling Pyridoxine Injection, 100 mg/mL, 30mL vials due to a lack of assurance of sterility. The recall affects 280 vials distributed nationwide and internationally.

    Product
    Pyridoxine Injection, 100 mg/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-0288-2016·2015-11-25

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

    US Compounding Inc is recalling 797 vials of Tri-Mix 30/1/10 injection due to deficient practices that may impact sterility assurance.

    Product
    Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil USP 10 mcg/mL), 5 mL Multi-Dose Vial, For Penile Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3256-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0291-2016·2015-11-25

    US Compounding Recalls Vancomycin Ophthalmic Preparations Due to Sterility Concerns

    US Compounding Inc is recalling 494 syringes of Vancomycin Ophthalmic PF due to deficient practices that may impact sterility assurance.

    Product
    Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0209-64
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0346-2016·2015-11-25

    Downing Labs Recalls Co-Enzyme Q-10 Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling Co-Enzyme Q-10 Injectable vials because the product lacks assurance of sterility. The recall covers all lots distributed in the US and internationally.

    Product
    Co-Enzyme Q-10 Injectable, 20mg/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-0337-2016·2015-11-25

    Downing Labs Recalls L-Glutamine Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling L-Glutamine Injectable vials because the company cannot assure the product's sterility. The recall covers all lots distributed in the US and internationally.

    Product
    L-Glutamine Injectable, 30mg/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-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-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-328-2016·2015-11-25

    Essential Wellness Pharma Recalls Testosterone Cypionate Injections Due to Sterility Concerns

    Essential Wellness Pharma is recalling 261 vials of Testosterone Cypionate 200 mcg/mL injection because poor sterile production practices resulted in a lack of sterility assurance.

    Product
    Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged 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-0245-2016·2015-11-25

    US Compounding Recalls Cyclo/PE/Tropic/Ketor Ophthalmic Drops for Sterility Concerns

    US Compounding Inc is recalling 1,198 bottles of compounded ophthalmic drops nationwide due to deficient practices that may impact sterility assurance.

    Product
    Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use, Rx. only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3044-07
    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-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-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-0255-2016·2015-11-25

    US Compounding Recalls Hyaluronic Acid Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 5,118 syringes of Hyaluronic Acid/Lidocaine PF due to deficient practices that may impact sterility assurance.

    Product
    Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe , For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3087-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0294-2016·2015-11-25

    US Compounding Recalls Zinc Sulfate Vials Due to Sterility Concerns

    US Compounding Inc is recalling 562 vials of Zinc Sulfate 1 mg/mL due to deficient practices that may impact sterility assurance.

    Product
    Zinc Sulfate (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3226-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0352-2016·2015-11-25

    Downing Labs Recalls Glucosamine HCL Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 20 vials of Glucosamine HCL Injectable because the product lacks assurance of sterility. The recall covers all lots distributed in the US and internationally.

    Product
    Glucosamine HCL 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-321-2016·2015-11-25

    Progesterone Injection Recalled for Lack of Sterility Assurance

    Essential Wellness Pharmacy is recalling Progesterone 100 mg/mL injections due to poor sterile production practices that compromised sterility assurance.

    Product
    Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0263-2016·2015-11-25

    US Compounding Recalls Medroxyprogesterone/Lidocaine Vials Due to Sterility Concerns

    US Compounding Inc is recalling 439 vials of Medroxyprogesterone/Lidocaine due to deficient practices that may impact sterility assurance.

    Product
    MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3113-07
    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-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-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-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