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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5501–5525 of 18015

  • SevereFDA (Drugs)·D-0384-2021·2021-05-26

    Pfizer Recalls Sterile Water Vials Due to Insect Particulate Matter

    Pfizer is recalling 49,525 vials of Sterile Water for Injection because an insect was found in one vial. The product is distributed nationwide.

    Product
    STERILE WATER — STERILE WATER (WATER)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0383-2021·2021-05-26

    FDA Recalls Triple SupremeZen Plus 3500 for Unapproved Tadalafil

    Hyobin LLC is recalling Triple SupremeZen Plus 3500 capsules because FDA analysis found the unapproved drug tadalafil. The product was marketed without an approved NDA or ANDA.

    Product
    Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0374-2021·2021-05-26

    Teva Recalls Leucovorin Calcium Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling specific lots of Leucovorin Calcium for Injection because the company cannot guarantee the product is sterile.

    Product
    Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01; ALSO LABELED UNDER: NOVAPLUS, Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 194
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0391-2021·2021-05-26

    Sun Pharma Recalls CEQUA Eye Drops for Subpotency and Particulates

    Sun Pharmaceutical Industries is recalling CEQUA (cyclosporine) ophthalmic solution due to subpotent drug levels and the presence of particulates.

    Product
    CEQUA — CEQUA (CYCLOSPORINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0543-2021·2021-05-26

    21st Century Vitamin D3 Tablets Recalled for Incorrect Labeling

    Twenty-First Century Healthcare is recalling 21st Century Vitamin D3 tablets because some bottles were mislabeled with a lower dosage.

    Product
    21st Century Vitamin D3 125 mcg (5000 IU) tablet, 100 count, UPC 7-40985-27431-6, 21st Century HealthCare, Inc., 2119 Wilson St., Tempe, AZ 85282
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0389-2021·2021-05-26

    Fresenius Recalls Delflex Peritoneal Dialysis Solution Due to Labeling Error

    Fresenius Medical Care is recalling 709 cases of Delflex Peritoneal Dialysis Solution because a 4.25% dextrose bag was found inside a 1.5% dextrose box.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0386-2021·2021-05-26

    KVK-Tech Recalls Hydrocodone and Homatropine Tablets for Impurity Failures

    KVK-Tech, Inc. is recalling 17,096 bottles of Hydrocodone Bitartrate and Homatropine Methylibromide tablets due to failed impurities and degradation specifications.

    Product
    HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE — HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0387-2021·2021-05-26

    Nomax Recalls Subpotent Dry Eye Test Fluorescein Sodium Strips

    Nomax Inc. is voluntarily recalling 78 cartons of Dry Eye Test strips due to subpotent drug content. The FDA classified this as a Class III recall.

    Product
    DRY EYE TEST — DRY EYE TEST (FLUORESCEIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0540-2021·2021-05-26

    Lopez Gonzalez Santana Recalls BTREX PLUS Dietary Supplement Due to Damaged Tablets

    Lopez Gonzalez Santana Corporation is recalling BTREX PLUS dietary supplement caplets due to the presence of damaged tablets, a Current Good Manufacturing Practice (CGMP) deviation.

    Product
    BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802 (Physician Samples)
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0373-2021·2021-05-19

    Chloraprep One-Step Applicator Recalled for Loose Endcap Releasing Glass Shards

    CareFusion 213, LLC is recalling Chloraprep One-Step applicators because the endcap may fall off during activation, releasing glass shards into the solution.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0372-2021·2021-05-19

    Sun Pharmaceutical Recalls Metformin Hydrochloride Tablets Due to Foreign Substance

    Sun Pharmaceutical Industries is recalling 50,868 bottles of Metformin Hydrochloride Extended-Release Tablets because activated carbon was found in the product.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0366-2021·2021-05-12

    Thumbs Up 7 Red 70K Recalled for Unapproved Sildenafil and Tadalafil

    Antoto-K is recalling Thumbs Up 7 Red 70K because FDA analysis found unapproved sildenafil and tadalafil. The product was marketed without an approved NDA or ANDA.

    Product
    Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC., Made in USA, UPC 6 17135 89467 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0368-2021·2021-05-12

    QMart Recalls Imperial Gold 2000 Male Enhancement Capsules

    QMart is recalling Imperial Gold 2000 male sexual performance enhancement capsules because FDA analysis found undeclared tadalafil and/or sildenafil.

    Product
    IMPERIAL GOLD 2000, Male Sexual Performance Enhancement, 1 Capsule, UPC 718122040702
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0369-2021·2021-05-12

    FDA Recalls PremierZen Extreme 3000 for Unapproved Active Ingredients

    QMart is recalling PremierZen Extreme 3000 capsules because FDA analysis found unapproved drugs tadalafil and/or sildenafil.

    Product
    PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0479-2021·2021-05-12

    Natrol Melatonin 3 mg Tablets Recalled for Mislabeling as ALA 300 mg

    Natrol LLC is recalling one lot of Melatonin 3 mg tablets that were mislabeled as ALA 300 mg capsules. The recall covers 12,740 units distributed across multiple US states and international locations.

    Product
    Natrol Melatonin 3 mg, Tab 60 White bottle with purple flip-top cap. Fall asleep faster, Stay asleep longer, 100$ Drug Free 1 Tablet 20 minutes before bedtime. Manufactured by Natrol LLC. Chatsworth, CA 91311 USA
    Category
    Drug
    Distribution
    36 states
  • ModerateFDA (Drugs)·D-0365-2021·2021-05-12

    Hand Sanitizer Recalled for Packaging Resembling Drinking Water Bottles

    PNHC, LLC. is recalling 139,806 bottles of Heal The World hand sanitizer because the packaging resembles drinking water bottles.

    Product
    heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70% Topical Solution, 9.6 FL OZ. (285 mL) bottle, Heal The World, LLC, Draper, UT 84020, UPC 6 19988 44038 0.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0358-2021·2021-05-12

    FDA Recalls Acetaminophen in Health Kits Due to Labeling Error

    A-S Medication Solutions is recalling Health Essentials Kits containing Acetaminophen 500mg tablets. The bottles were incorrectly labeled with prescription drug labels instead of OTC labels.

    Product
    ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0344-2021·2021-05-05

    ChloraPrep One-Step Recalled for Fungal Contamination and Package Breach

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because fungal growth breached package integrity. The product is a sterile skin antiseptic.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0343-2021·2021-05-05

    FDA Recalls Chloraprep One-Step Antiseptic Due to Fungal Contamination

    CareFusion 213, LLC is recalling Chloraprep One-Step antiseptic applicators because fungal growth breached package integrity. The product is distributed nationwide and internationally.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide