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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4901–4925 of 8589

  • SevereFDA (Drugs)·D-0876-2016·2016-06-01

    Akorn Recalls PerioRx Oral Rinse Due to Unknown Impurity

    Akorn, Inc. is recalling PerioRx oral rinse because multiple batches failed impurity specifications. The product contains an unknown impurity of chlorhexidine gluconate.

    Product
    PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0886-2016·2016-06-01

    Real Skill Recalled for Marketing Without FDA Approval

    R Thomas Marketing, LLC is recalling Real Skill capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0872-2016·2016-06-01

    Sanofi Recalls Auvi-Q Epinephrine Auto-Injectors Due to Defective Delivery System

    Sanofi-Aventis is recalling Auvi-Q epinephrine auto-injectors because a defective delivery system may result in inaccurate dosage delivery.

    Product
    Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0896-2016·2016-06-01

    FDA Recalls Black Storm Capsules Marketed Without Approval

    R Thomas Marketing, LLC is recalling Black Storm capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Black Storm, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0901-2016·2016-06-01

    Man King capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling Man King capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Man King, packaged in BIG BOX (8 small boxes / 5 capsules per box / 40 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0898-2016·2016-06-01

    Happy Passengers Recalled for Lack of FDA Approval

    R Thomas Marketing, LLC is recalling Happy Passengers capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Happy Passengers, packaged in BIG BOX (30 small boxes / 1 capsule per box / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0867-2016·2016-06-01

    Fresenius Kabi Recalls Octreotide Acetate Injection Due to Impurities

    Fresenius Kabi USA is recalling Octreotide Acetate Injection vials because they failed impurities and degradation specifications.

    Product
    OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0890-2016·2016-06-01

    FDA Recalls Bull Capsules Marketed Without FDA Approval

    R Thomas Marketing, LLC is recalling Bull capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Bull, packaged in CASE (10 packs / 3 capsules per can / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0903-2016·2016-06-01

    Night Man capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling Night Man capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Night Man, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0893-2016·2016-06-01

    FDA Recalls African Superman Supplements Marketed Without Approval

    R Thomas Marketing, LLC is recalling African Superman supplements because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0884-2016·2016-06-01

    FDA Recalls Black Ant Supplements Marketed Without Approval

    The FDA is recalling Black Ant supplements distributed by R Thomas Marketing, LLC because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0899-2016·2016-06-01

    Plant Vigra Recalled for Lack of FDA Approval

    R Thomas Marketing, LLC is recalling Plant Vigra because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Plant Vigra, packaged in BIG BOX / (18 cans / 6 capsules per can / 108 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0891-2016·2016-06-01

    Bull's Genital Recalled for Marketing Without FDA Approval

    R Thomas Marketing, LLC is recalling Bull's Genital capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100 capsules),Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0907-2016·2016-06-01

    FDA Recalls Zhen Gong Fu for Lack of Approved New Drug Application

    R Thomas Marketing, LLC is recalling Zhen Gong Fu capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Zhen Gong Fu, packaged in BIG BOX (16 small boxes / 2 capsules per box / 32 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0892-2016·2016-06-01

    FDA Recalls Unapproved Zhong Hua Niu Bian Capsules Nationwide

    R Thomas Marketing, LLC is recalling Zhong Hua Niu Bian capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Zhong Hua Niu Bian, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0853-2016·2016-05-25

    Keystone Recalls Better Braid Un-Braid Due to Microbial Contamination

    Keystone Laboratories is recalling Better Braid Un-Braid salicylic acid product due to a failed S. aureus test. The product was distributed in Maryland and New Jersey.

    Product
    BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEYSTONE LABORATORIES, UPC 07059600430.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0855-2016·2016-05-25

    Renovo Patch Recalled for Lack of Approval and Subpotency

    TMIG Inc is recalling Renovo Patch because it was marketed without FDA approval and three lots were found to be subpotent.

    Product
    Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0826-2016·2016-04-27

    Impax Recalls Dextroamphetamine Sulfate Tablets Due to Failed Impurity Specifications

    Impax Laboratories is recalling specific lots of Dextroamphetamine Sulfate Tablets because they failed impurity and degradation specifications.

    Product
    Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0832-2016·2016-04-27

    Hospira Recalls Potassium Chloride Injection Bags Due to Chemical Contamination

    Hospira Inc. is recalling 81,888 bags of Potassium Chloride Injection due to potential contamination with an aromatic hydrocarbon resin.

    Product
    Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7077-14
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0828-2016·2016-04-27

    Hospira Recalls Dextrose Injection Bags Due to Chemical Contamination

    Hospira Inc. is recalling 4,368 bags of Dextrose Injection, USP, 50% due to potential contamination with an aromatic hydrocarbon resin.

    Product
    Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7936-19, Barcode (01) 0 030409 793619 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0825-2016·2016-04-27

    Impax Recalls Dextroamphetamine Sulfate Tablets Due to Failed Impurity Specifications

    Impax Laboratories is recalling 67,428 bottles of Dextroamphetamine Sulfate Tablets USP, 10 mg, because the product failed impurities and degradation specifications.

    Product
    Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0829-2016·2016-04-27

    Hospira Recalls Dextrose Injection Bags Due to Chemical Contamination Risk

    Hospira Inc. is recalling 552 bags of Dextrose Injection, USP, 20% due to potential contamination with an aromatic hydrocarbon resin.

    Product
    Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7935-19, Barcode (01) 0 030409 793519 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0804-2016·2016-04-13

    Meditech Formula 9 Injection Recalled for Sterility Assurance Issues

    Meditech Laboratories is recalling Formula 9 Injection vials due to incomplete production data regarding sterility assurance.

    Product
    Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0803-2016·2016-04-13

    Meditech Formula 4 Injection Recalled for Sterility Assurance Issues

    Meditech Laboratories is recalling Formula 4 Injection vials due to incomplete data regarding production sterility.

    Product
    Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. .
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0808-2016·2016-04-13

    Meditech Formula 2 Vials Recalled Due to Expired Active Ingredient

    Meditech Laboratories is recalling Formula 2 vials because an active ingredient expired before the labeled Beyond Use Date.

    Product
    Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
    Category
    Drug
    Distribution
    Distributed nationwide