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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8126–8150 of 11823

  • 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-0290-2016·2015-11-25

    US Compounding Recalls Tropicamide and Phenylephrine Ophthalmic Drops

    US Compounding Inc is recalling 751 bottles of Tropicamide 1%/Phenylephrine 2.5% ophthalmic drops due to deficient practices that may impact sterility assurance.

    Product
    Tropicamide 1%/Phenylephrine 2.5% (tropicamide USP 10 mg/ phenylephrine HCL USP 25 mg), 10 mL Ophthalmic Dropper, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3214-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0259-2016·2015-11-25

    US Compounding Recalls Choline Chloride Inositol Cyanocobalamin Injection Vials

    US Compounding Inc is recalling 103 vials of a compounded injection due to deficient practices that may impact sterility assurance.

    Product
    Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3294-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0236-2016·2015-11-25

    US Compounding Recalls Acetylcysteine 10% Ophthalmic Solution for Sterility Concerns

    US Compounding Inc is recalling Acetylcysteine 10% Ophthalmic solution due to deficient practices that may impact sterility assurance.

    Product
    ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032.
    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-0385-2016·2015-11-25

    Solutions Rx Pharmacy Recalls Budesonide Capsules Due to Penicillin Contamination

    Solutions Rx Pharmacy is recalling compounded budesonide nasal rinse capsules due to possible penicillin cross-contamination in the bulk powder.

    Product
    c-Budesonide 0.6MG capsules, 60-count bottle, NOT FOR ORAL USE-USE IN NASAL RINSE OR NEBULIZER, SOLUTIONS Rx PHARMACY, 2705 4TH AVENUE SOUTH, BIRMINGHAM, AL 35233
    Category
    Drug
    Distribution
    4 states
  • 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-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-0265-2016·2015-11-25

    US Compounding Recalls Methylprednisolone Vials Due to Sterility Concerns

    US Compounding Inc is recalling 3,629 vials of Methylprednisolone 100 mg/mL due to deficient practices that may impact sterility assurance.

    Product
    MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3115-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0370-2016·2015-11-25

    Downing Labs Recalls L-Glutathione Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 467 vials of L-Glutathione Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.

    Product
    L-Glutathione 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-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-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-0252-2016·2015-11-25

    US Compounding Recalls Fentanyl Syringes Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 711 fentanyl syringes nationwide because deficient practices may have impacted sterility assurance.

    Product
    Fentanyl PF 50 mL (25 mcg/mL), 10 mL Single Use Syringe, For IV, IM or SC injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0002-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0368-2016·2015-11-25

    Downing Labs Recalls L-Arginine Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling L-Arginine Injection, 100mg/mL, 30mL vials because the company cannot assure the sterility of the product.

    Product
    L-Arginine 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-0379-2016·2015-11-25

    Downing Labs Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 34 vials of Testosterone Cypionate Injection due to a lack of assurance of sterility. The product was distributed nationwide and internationally.

    Product
    Testosterone Cypionate Injection (Sesame Oil), 200mg/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-0238-2016·2015-11-25

    US Compounding Recalls Betamethasone Vials Due to Sterility Concerns

    US Compounding Inc is recalling 19,494 vials of Betamethasone Combo 10 mL due to deficient practices that may impact sterility assurance.

    Product
    Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-10
    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-0246-2016·2015-11-25

    US Compounding Recalls Cyclopent/PE/Tropic Eye Drops Due to Sterility Concerns

    US Compounding Inc is recalling 820 bottles of Cyclopent/PE/Tropic eye drops because deficient practices may have compromised sterility assurance.

    Product
    Cyclopent/PE/Tropic 2mL (1%/2.5%/0.25%), 2 mL dropper bottles; For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02
    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-0248-2016·2015-11-25

    US Compounding Recalls Dex LA 8 Vials Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 4,333 vials of Dex LA 8 (Dexamethasone acetate) nationwide because deficient practices may have impacted sterility assurance.

    Product
    Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02
    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-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-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-0272-2016·2015-11-25

    US Compounding Recalls Omnipaque 300 Vials Due to Sterility Concerns

    US Compounding Inc is recalling 8,218 vials of Omnipaque 300 injection due to deficient practices that may impact sterility assurance.

    Product
    Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3137-02
    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