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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3451–3475 of 8589

  • SevereFDA (Drugs)·D-0898-2018·2018-07-11

    SCA Pharmaceuticals Recalls Norepinephrine Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate bags due to a potential for leakage that compromises sterility.

    Product
    Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0903-2018·2018-07-11

    SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling 400 bags of Phenylephrine HCL 20 mg in 0.9% Sodium Chloride due to a potential for leakage that compromises sterility.

    Product
    Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0890-2018·2018-07-11

    Ingenus Recalls Irinotecan Hydrochloride Injection Due to Potency Issues

    Ingenus Pharmaceuticals is recalling specific lots of Irinotecan Hydrochloride Injection because they had high out-of-specification assay values for potency.

    Product
    IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0902-2018·2018-07-11

    SCA Pharmaceuticals Recalls Phenylephrine Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling 451 bags of Phenylephrine HCL due to potential leakage that compromises sterility.

    Product
    Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0889-2018·2018-07-04

    Advanced Pharma Recalls Subpotent Fentanyl Citrate Prefilled Syringes

    Advanced Pharma Inc. is recalling 100 prefilled syringes of fentanyl citrate because the final drug concentration is subpotent compared to the label.

    Product
    fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0885-2018·2018-06-27

    ICU Medical Recalls 5% Dextrose Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 5% Dextrose Injection bags because they may leak, compromising sterility. The recall covers 267,288 bags distributed nationwide and in Canada.

    Product
    5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0881-2018·2018-06-27

    ICU Medical Recalls 0.45% Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical Inc. is recalling 88,960 bags of 0.45% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.

    Product
    0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0882-2018·2018-06-27

    ICU Medical Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 941,496 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.

    Product
    0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0883-2018·2018-06-27

    ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 525,984 bags of 0.9% Sodium Chloride Injection due to potential leaks that compromise sterility. The product was distributed nationwide and in Canada.

    Product
    0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0884-2018·2018-06-27

    ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical Inc is recalling 0.9% Sodium Chloride Injection bags because they may leak, compromising sterility. The recall covers lots distributed nationwide and in Canada.

    Product
    0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0875-2018·2018-06-20

    Allergan Recalls Taytulla Contraceptive Softgels Due to Out-of-Sequence Tablets

    Allergan is recalling Taytulla softgel capsules because the tablets are out of sequence. This affects 168,768 blister cards distributed nationwide.

    Product
    TAYTULLA — TAYTULLA (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0858-2018·2018-06-20

    FDA Recalls X-Jow Pain Gel Due to Potential Bacterial Contamination

    Shadow Holdings DBA Bocchi Labs is recalling X-Jow Pain Gel because CGMP deviations may have allowed bacterial contamination.

    Product
    X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0861-2018·2018-06-20

    Acne Shave 3 Step Shaving System Recalled for Bacterial Contamination Risk

    Shadow Holdings DBA Bocchi Labs is recalling the Acne Shave 3 Step Shaving System due to CGMP deviations that may result in bacterial contamination.

    Product
    Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic acid) Shave Cream Acne Shield, one tube Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5% tube, and one Power Shaver per box, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos C
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0860-2018·2018-06-20

    Acne Shave Shave Cream Recalled for Potential Bacterial Contamination

    Shadow Holdings DBA Bocchi Labs is recalling Acne Shave Shave Cream due to CGMP deviations that may allow bacterial contamination.

    Product
    Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL) tube, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos, CA 90703 USA, UPC 7 80707 73111 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0854-2018·2018-06-20

    PharMEDium Recalls Hydromorphone Syringes Due to Potency Issues

    PharMEDium Services is recalling 2,800 hydromorphone syringes nationwide because some units were found to be superpotent or subpotent.

    Product
    HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0864-2018·2018-06-20

    Inopak Recalls Antibacterial Foaming Hand Wash Due to Microbial Contamination

    Inopak Ltd is recalling Option Systems Antibacterial Foaming Hand Wash because FDA analysis found out-of-specification microbial counts.

    Product
    Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0906-2018·2018-06-13

    Hospira Recalls Naloxone Hydrochloride Injection Due to Particulate Matter

    Hospira is recalling Naloxone Hydrochloride Injection cartridges due to the presence of particulate matter on the syringe plunger.

    Product
    NALOXONE HYDROCHLORIDE — NALOXONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0879-2018·2018-06-06

    Poseidon Platinum 4500 Recalled for Undeclared Sildenafil and Tadalafil

    Shoreside Enterprises Inc. is recalling Poseidon Xtreme PLATINUM 4500 because FDA analysis found undeclared sildenafil and tadalafil, making it an unapproved drug.

    Product
    POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0880-2018·2018-06-06

    FDA Recalls 7K Capsules Containing Undeclared Sildenafil and Tadalafil

    The FDA is recalling 7K capsules distributed by SX Power Co. because they contain undeclared sildenafil and tadalafil, making them unapproved drugs with unestablished safety and efficacy.

    Product
    7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0821-2018·2018-05-30

    FDA Recalls Rhino 69 Extreme 50000 for Undeclared Tadalafil

    The FDA is recalling Rhino 69 Extreme 50000 capsules because they contain undeclared tadalafil, an unapproved drug with unestablished safety and efficacy.

    Product
    Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0827-2018·2018-05-30

    Fresenius Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

    Fresenius Medical Care is recalling 25,356 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility.

    Product
    0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0834-2018·2018-05-30

    Ideaz Recalls Screamin' Hot Pain Gel Due to Benzene Levels

    Ideaz LLC is recalling Screamin' Hot Pain Relieving Gel because it was manufactured with benzene levels exceeding FDA limits.

    Product
    screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141g) tubes, UPC 7 50263 80007 6; and c) 16 oz. (454g) bottles, UPC 7 50263 80076 2; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-80
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0822-2018·2018-05-30

    Mylan Recalls Loxapine Capsules Due to Cross-Contamination Risk

    Mylan Institutional, Inc. is recalling Loxapine Capsules 25 mg due to cGMP violations that create a risk of cross-contamination.

    Product
    Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1480-2018·2018-05-30

    FDA Recalls Nature's Only Choice B17 Apricot Extract Dietary Supplement

    Nature's Only Choice is recalling B17 Bitter Raw Apricot Extract Amygdalin dietary supplements because the product is considered an unapproved new drug.

    Product
    Nature's Only Choice B17 BITTER RAW APRICOT EXTRACT AMYGDALIN Dietary Supplement 100 Capsules
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0835-2018·2018-05-30

    Ideaz Recalls Screamin' Menthol Pain Gel Due to Benzene Levels

    Ideaz Llc is recalling Screamin' Menthol Pain Relieving Gel because it contains benzene levels exceeding FDA limits.

    Product
    screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141g) tubes, UPC 7 50263 80006 9; and c) 16 oz. (454g) bottles, UPC 7 50263 80066 3; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-801
    Category
    Drug
    Distribution
    Distributed nationwide