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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5276–5300 of 8589

  • SevereFDA (Drugs)·D-0344-2016·2015-11-25

    Downing Labs Recalls Riboflavin-5-Phosphate Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling Riboflavin-5-Phosphate Injectable vials because the company cannot ensure the product is sterile.

    Product
    Riboflavin-5-Phosphate 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-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-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-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-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-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-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-0354-2016·2015-11-25

    Downing Labs Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 186 vials of Methylcobalamin Buffered Injectable because the company cannot ensure the product is sterile.

    Product
    Methylcobalamin Buffered Injectable, 5mg/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-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-0382-2016·2015-11-25

    Downing Labs Recalls Thiotic Acid Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling Thiotic Acid Injection because the company cannot ensure the product is sterile. The recall affects 7 vials distributed in the US and 17 other countries.

    Product
    Thiotic Acid Injection, 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-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-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-314-2016·2015-11-25

    Essential Wellness Recalls Methylcobalamin Injections Due to Sterility Concerns

    Essential Wellness Pharmacy is recalling Methylcobalamin 1 mg/mL prefilled syringes due to poor sterile production practices that compromised sterility assurance.

    Product
    Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-307-2016·2015-11-25

    FDA Recalls HCG and Lidocaine Injections Due to Sterility Concerns

    Kalman Health & Wellness is recalling HCG 1000 U/LIDO 0.2% Injection vials due to poor sterile production practices that compromised sterility assurance.

    Product
    HCG 1000 U/ LIDO 0.2%/mL Injection, packaged in a) 3 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    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-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-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-0271-2016·2015-11-25

    US Compounding Recalls Neostigmine Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 15,640 vials of Neostigmine 5 mg/5 mL syringes nationwide due to deficient practices that may impact sterility assurance.

    Product
    Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3132-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0384-2016·2015-11-25

    Downing Labs Recalls Methylcobalamin Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 315 vials of Methylcobalamin Injection Buffered 5mg/mL due to a lack of assurance of sterility. The product was distributed nationwide and internationally.

    Product
    Methylcobalamin Injection Buffered 5mg/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-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-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-302-2016·2015-11-25

    Essential Wellness Pharma Recalls Cyclosporin Eye Drops Due to Sterility Concerns

    Essential Wellness Pharma is recalling specific lots of Cyclosporin 0.1% Opth Solution because poor sterile production practices created a lack of sterility assurance.

    Product
    Cyclosporin 0.1% 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-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