The Recall Desk

Hazard

Mis Labeling recalls

9,607 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9,607
Critical
160
Severe
588
Most recent
2026-09-10

Of the 9,607 mis labeling recalls we have scored against our rubric, 160 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 588 (6%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all mis labeling recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

4051–4075 of 9607

  • ModerateFDA (Drugs)·D-0202-2018·2018-01-17

    KRS Global Biotechnology Recalls Ophthalmic Solution Due to Labeling Errors

    KRS Global Biotechnology is recalling 81 droptainers of a multi-dose ophthalmic solution because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5% Ophthalmic Soln, 5 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0165-2018·2018-01-17

    KRS Global Biotechnology Recalls Benzocaine Cream Due to Labeling Errors

    KRS Global Biotechnology is recalling 4,530 jars of Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0186-2018·2018-01-17

    KRS Global Biotechnology Recalls Oxytocin IV Bags Due to Labeling Errors

    KRS Global Biotechnology is recalling 963 bags of Oxytocin 30 Units IV solution because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For IV Infusion Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0195-2018·2018-01-17

    KRS Global Biotechnology Recalls Sermorelin Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 597 vials of Sermorelin and related peptides because the Beyond Use Date exceeds the expiration of at least one ingredient.

    Product
    Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0206-2018·2018-01-17

    FDA Recalls 7-Keto DHEA Capsules Due to Expired Ingredient

    KRS Global Biotechnology is recalling 7-Keto DHEA 100 mg capsules because the product's expiration date exceeds the expiration date of at least one ingredient.

    Product
    7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0170-2018·2018-01-17

    KRS Global Biotechnology Recalls Chloramphenicol and Amphotericin Otic Powder

    KRS Global Biotechnology is recalling 20 jars of Chloramphenicol and Amphotericin Otic Powder because the Beyond Use Date exceeds the expiration of at least one ingredient.

    Product
    Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0199-2018·2018-01-17

    KRS Global Biotechnology Recalls Trimix #23F Due to Incorrect Expiration Date

    KRS Global Biotechnology is recalling 94 vials of Trimix #23F because the product's expiration date exceeds the expiration date of at least one ingredient.

    Product
    Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0156-2018·2018-01-17

    SCA Pharmaceuticals Recalls Ephedrine Sulfate Syringes Due to Missing Labeling

    SCA Pharmaceuticals is recalling 1,248 syringes of Ephedrine sulfate 5 mg/mL because the product labels were missing the lot number and beyond-use date.

    Product
    Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0173-2018·2018-01-17

    KRS Global Recalls Human Chorionic Gonadotropin Tablets Due to Labeling Error

    KRS Global Biotechnology is recalling 2,239 Human Chorionic Gonadotropin tablets because the expiration date exceeds the shelf life of an ingredient.

    Product
    Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0178-2018·2018-01-17

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Vials for Labeling Errors

    KRS Global Biotechnology is recalling 2,274 vials of Human Chorionic Gonadotropin 20,000 iu due to incorrect or missing lot and expiration dates.

    Product
    Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0172-2018·2018-01-17

    KRS Global Biotechnology Recalls Estriol Cream Due to Expired Ingredient

    KRS Global Biotechnology is recalling 300 jars of Estriol 0.1% Cream because the product's beyond-use date exceeds that of at least one ingredient.

    Product
    Estriol 0.1% (1 mg/gm) Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0203-2018·2018-01-17

    KRS Global Biotechnology Recalls Vitamin 9 Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 479 vials of Vitamin 9 Lyophilized Vial due to incorrect or missing lot and expiration dates.

    Product
    Vitamin 9 Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0179-2018·2018-01-17

    KRS Global Biotechnology Recalls Hydroquinone and Tretinoin Ointment Jars

    KRS Global Biotechnology is recalling 30 jars of Hydroquinone 8%/Tretinoin 0.1% Topical Ointment because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0185-2018·2018-01-17

    FDA Recalls Nicotinamide Adenine Dinucleotide Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 2,535 vials of Nicotinamide Adenine Dinucleotide 500 mg because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0183-2018·2018-01-17

    KRS Global Biotechnology Recalls Liothyronine SR Capsules Due to Labeling Errors

    KRS Global Biotechnology is recalling Liothyronine SR 20 mcg capsules because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Liothyronine SR (T3) 20 mcg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0161-2018·2018-01-17

    KRS Global Biotechnology Recalls Anastrozole 0.5 mg Capsules for Labeling Errors

    KRS Global Biotechnology is recalling 15,700 capsules of Anastrozole 0.5 mg due to incorrect or missing lot and expiration dates.

    Product
    Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0204-2018·2018-01-17

    KRS Global Biotechnology Recalls Vitamin 9 A/B Lyophilized Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 3,612 vials of Vitamin 9 A/B Lyophilized Vials because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0184-2018·2018-01-17

    KRS Global Biotechnology Recalls Methylene Blue Injectable Vials for Labeling Errors

    KRS Global Biotechnology is recalling 696 vials of Methylene Blue (PF) 10 mg/mL Injectable due to incorrect or missing lot and expiration dates.

    Product
    Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0168-2018·2018-01-17

    FDA Recalls Bi-Est Cream Due to Expired Ingredient Dates

    KRS Global Biotechnology is recalling 300 jars of Bi-Est Cream because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0176-2018·2018-01-17

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Labeling Errors

    KRS Global Biotechnology is recalling 2,239 vials of Human Chorionic Gonadotropin because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0153-2018·2018-01-17

    Enoxaparin Sodium Injection Recalled for Labeling Error on Declared Strength

    Sanofi-Aventis is recalling Enoxaparin Sodium injections because a single syringe with a different strength was found in a carton labeled 120 mg/0.8 mL.

    Product
    ENOXAPARIN SODIUM — ENOXAPARIN SODIUM (ENOXAPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0316-2018·2018-01-10

    Amendia Recalls Ceres Self-Drilling Variable Screws Due to Incorrect Length Marking

    Amendia, Inc. is recalling 40 Ceres Self-Drilling Variable Screws because some units marked as 12 mm actually measure 14 mm in length.

    Product
    Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-0519-2018·2018-01-10

    New Seasons Market Recalls Buttermilk Herb Side Salad for Undeclared Wheat

    New Seasons Market is recalling Buttermilk Herb Side Salad because the croutons contain wheat, which is not declared on the label.

    Product
    Buttermilk Herb Side Salad, prepacked in a clear plastic container, sold by the unit for $2.99, UPC 252326-602998.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0298-2018·2018-01-10

    Zimmer Biomet Recalls Hip Fracture Stem Due to Internal Label Error

    Zimmer Biomet is recalling specific hip fracture stems because the internal patient label may be incorrect, although the outer box and product are correctly identified.

    Product
    COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
    Category
    Medical Device
    Distribution
    Distributed nationwide