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 the agency’s own highest classification or reported deaths or serious injuries, 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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12776–12800 of 18028

  • 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-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-0345-2016·2015-11-25

    Downing Labs Recalls Procaine Injectables Due to Sterility Concerns

    Downing Labs, LLC is recalling 881 vials of Procaine Injectables because the company cannot ensure the product is sterile. The affected vials were distributed in the US and 17 other countries.

    Product
    Procaine Injectables 20mg/mL and 2%, 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-306-2016·2015-11-25

    Essential Wellness Pharma Recalls HCG Injections Due to Sterility Concerns

    Essential Wellness Pharma is recalling 49 vials of HCG 1000 Units/mL injections nationwide due to poor sterile production practices that compromise sterility assurance.

    Product
    HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and h) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0359-2016·2015-11-25

    Downing Labs Recalls DMPS Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling DMPS Injectable vials because the company cannot ensure the product is sterile.

    Product
    DMPS Injectable, 50mg/mL, 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-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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0293-2016·2015-11-25

    US Compounding Recalls Voriconazole Eye Drops Due to Sterility Concerns

    US Compounding Inc is recalling specific lots of Voriconazole eye drops because deficient practices may have compromised sterility assurance.

    Product
    Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2815-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0356-2016·2015-11-25

    Downing Labs Recalls Chromium Injectable Due to Sterility Assurance Concerns

    Downing Labs, LLC is recalling all lots of Chromium Injectable, 200mg/mL, 30mL vials because the product lacks assurance of sterility.

    Product
    Chromium 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-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-0276-2016·2015-11-25

    US Compounding Recalls Phenylephrine PF Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 14,580 vials of Phenylephrine PF IV syringes nationwide due to deficient practices that may impact sterility assurance.

    Product
    Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3159-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0261-2016·2015-11-25

    US Compounding Recalls Lidocaine Syringes Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 7,320 syringes of Lidocaine 1% PF for IV injection because deficient practices may have impacted sterility assurance.

    Product
    Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3099-07
    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-333-2016·2015-11-25

    Essential Wellness Pharma Recalls TRIMIX #2 Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling TRIMIX #2 Injection vials because poor sterile production practices resulted in a lack of sterility assurance for the finished drugs.

    Product
    TRIMIX #2 (24 mg-0.8 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-0341-2016·2015-11-25

    Downing Labs Recalls Acetyl-L-Carnitine Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling Acetyl-L-Carnitine and L-Carnitine injectable vials due to a lack of assurance of sterility. The products were distributed nationwide and internationally.

    Product
    Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500mg/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-298-2016·2015-11-25

    Essential Wellness Pharma Recalls Acetylcysteine Eye Drops Due to Sterility Concerns

    Essential Wellness Pharma is recalling Acetylcysteine 10% Ophthalmic Solution due to poor sterile production practices that compromised sterility assurance.

    Product
    Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    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-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-0286-2016·2015-11-25

    US Compounding Recalls Triamcinolone Diacetate Vials Due to Sterility Concerns

    US Compounding Inc is recalling 13,843 vials of Triamcinolone diacetate USP (40 mg/mL) nationwide due to deficient practices that may impact sterility assurance.

    Product
    Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3205-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0339-2016·2015-11-25

    Downing Labs Recalls L-Tryptophan Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 16 vials of L-Tryptophan Injectable because the company cannot assure the product's sterility.

    Product
    L-Tryptophan 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-0257-2016·2015-11-25

    US Compounding Recalls Hyaluronic Acid Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 105 syringes of Hyaluronic Acid/Lidocaine due to deficient practices that may impact sterility assurance.

    Product
    Hyaluronic Acid/Lidocaine (20 mg/1%/2 mL), 3 mL Single Use Syringe, For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0357-2016·2015-11-25

    Downing Labs Recalls EDTA Calcium Disodium Injectable Due to Sterility Concerns

    Downing Labs is recalling 104 vials of EDTA Calcium Disodium Injectable because the company cannot assure the product's sterility.

    Product
    EDTA Calcium Disodium Injectable, 300mg/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-0375-2016·2015-11-25

    Downing Labs Recalls Dexpanthenol Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 235 vials of Dexpanthenol Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.

    Product
    Dexpanthenol Injection, 250mg/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-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-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-0369-2016·2015-11-25

    Downing Labs Recalls DMSO 99% Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling DMSO 99% Injection vials because the product lacks assurance of sterility. The recall affects 187 vials distributed in the US and internationally.

    Product
    DMSO 99% Injection, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide