The Recall Desk

Hazard

Incorrect Dosage recalls

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

What the numbers show

Total
60
Critical
0
Severe
39
Most recent
2024-06-12

Of the 60 incorrect dosage recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 39 (65%) 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 incorrect dosage 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.

1–25 of 60

  • ModerateFDA (Drugs)·D-0537-2024·2024-06-12

    Cephalexin oral suspension recalled for incorrect label dosage amount

    Bryant Ranch Prepack is recalling Cephalexin oral suspension (125mg/5mL) due to back label errors stating the dose as 2.5g instead of the correct 5g per bottle. No illnesses have been reported.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0088-2024·2023-11-15

    Synthroid Levothyroxine Tablets Recalled for Incorrect Barcode Labeling

    AbbVie is recalling 864 cartons of Synthroid (Levothyroxine Sodium) 125mcg tablets due to incorrect barcode labeling. About 1 in 40 blister packs has a barcode showing 200mcg instead of 125mcg, risking dosage confusion.

    Product
    SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-1170-2023·2023-09-13

    Digoxin Tablets Recalled Due to Reversed Dosage Labeling

    Marlex Pharmaceuticals is recalling Digoxin Tablets because bottles labeled as 0.125mg contain 0.25mg strength, and vice versa. Approximately 94 100-count bottles distributed nationwide are affected.

    Product
    Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1290-2020·2020-06-17

    Lupin Recalls Lisinopril 5 mg Tablets Due to Product Mix-Up

    Lupin Pharmaceuticals is recalling 4,224 bottles of Lisinopril 5 mg tablets because 10 mg tablets were found in the bottles.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1361-2020·2020-03-11

    CareFusion Alaris Syringe Module Software Error Recall

    CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.

    Product
    CareFusion Alaris Syringe Module, Model 8110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1395-2019·2019-06-19

    Pecgen DMX Recalled for Incorrect Pediatric Dosage Labeling

    Novis PR, Inc. is recalling Pecgen DMX cough syrup because a typo on the label provides incorrect dosage instructions for children.

    Product
    PECGEN DMX — PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0383-2019·2019-01-30

    Bound Tree Medical Recalls Epi Safe Kits Due to Incorrect Instructions

    Bound Tree Medical is recalling Epi Safe Administration and Training Kits because the instructions recommend an unapproved epinephrine dosage for young children.

    Product
    curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe Administration Kit (8600-01101), 1 Epi Safe Training Kit (8600-01102), Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0384-2019·2019-01-30

    Recall of Curaplex Epi Safe Kits Due to Incorrect Epinephrine Instructions

    Bound Tree Medical is recalling Curaplex Epi Safe Kits because the instructions recommend an unapproved epinephrine dosage for young children.

    Product
    curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syringe " 1 Safety Needle " 2 Alcohol Prep Pads " 1 Adhesive Dressing " 1 Insert, Rx Only. Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Eme
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0385-2019·2019-01-30

    Bound Tree Medical Recalls Curaplex Epi Safe Training Kits Due to Labeling Errors

    Bound Tree Medical is recalling 2,654 Curaplex Epi Safe training kits because the instructions recommend an unapproved epinephrine dosage for young children.

    Product
    Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0009-2019·2018-10-10

    Endo Pharmaceuticals Recalls Robaxin-750 Due to Incorrect Dosage Labeling

    Endo Pharmaceuticals is recalling 2,856 bottles of Robaxin-750 (methocarbamol) because the labels contain incorrect dosage instructions.

    Product
    robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2018·2018-05-16

    Bard BrachySource Iodine-125 Radioactive Seeds Recalled for Dosage Mix-Up

    Bard Brachytherapy is recalling Iodine-125 radioactive seeds because incorrect dosage levels were mixed up and sent to two hospitals in California and Georgia.

    Product
    BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emis
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0380-2018·2018-01-24

    RayStation 6 Proton QA Module Recall for Potential Dosage Errors

    RaySearch Laboratories is recalling RayStation 6 software due to a defect in the proton QA module that may result in incorrect patient dosage calculations.

    Product
    RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to admin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0491-2017·2017-03-08

    Mylan Recalls Glipizide Extended-Release Tablets Due to Foreign Tablet Presence

    Mylan Pharmaceuticals is recalling 1,338 bottles of Glipizide 5 mg Extended-Release Tablets because they may contain 10 mg tablets.

    Product
    glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0078-2017·2016-10-19

    TheraSphere Y-90 Microspheres Recalled for Incorrect Radioactivity Labeling

    Biocompatibles U.K., Ltd. is recalling one dose of TheraSphere Y-90 Glass Microspheres shipped to Hong Kong because the labeled radioactivity was incorrect.

    Product
    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-0557-2016·2016-01-06

    Elekta Recalls MOSAIQ Oncology System Due to Dosage Calculation Error

    Elekta, Inc. is recalling 399 units of the MOSAIQ Oncology Information System because a software issue with age and weight data can cause incorrect drug dosages.

    Product
    MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1578-2015·2015-05-13

    Philips EPIQ 5 Ultrasound Systems Recalled for Pediatric BSA Calculation Error

    Philips is recalling EPIQ 5 Ultrasound Systems with the Pediatric Cardiology option because a unit conversion error may cause incorrect Body Surface Area calculations.

    Product
    EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453561772611 (1.2.1) 453561786571 (1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1244-2015·2015-03-11

    Elekta Focal Sim radiation therapy system recalled for image statistics error

    Elekta, Inc. is recalling 907 Focal Sim radiation therapy treatment planning systems because the Monaco Image Statistics Tool may produce incorrect CT to ED values.

    Product
    Focal Sim radiation therapy treatment planning system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-541-2013·2013-06-12

    TG United Recalls Trigofen Drops Due to Underdosing and Dosage Errors

    TG United, Inc. is recalling specific lots of Trigofen Drops because the products are underdosed or have an incorrect dosage regime.

    Product
    Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-522-2013·2013-06-12

    TG United Recalls Maxifed DM Due to Underdosing and Incorrect Dosage Regime

    TG United, Inc. is recalling Maxifed DM tablets because they are underdosed or have an incorrect dosage regime.

    Product
    Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-544-2013·2013-06-12

    TG United Recalls Z-Dex Syrup Due to Underdosing and Incorrect Dosage

    TG United, Inc. is recalling 2,388 bottles of Z-Dex Syrup because the product is underdosed or has an incorrect dosage regime.

    Product
    Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-546-2013·2013-06-12

    TG United Recalls ZoDen PD Nasal Spray Due to Dosage Errors

    TG United, Inc. is recalling ZoDen PD nasal spray bottles because the products are underdosed or have an incorrect dosage regime.

    Product
    ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-525-2013·2013-06-12

    TG United Recalls BroveX PSE DM Due to CGMP Deviations

    TG United, Inc. is recalling BroveX PSE DM bottles because they are underdosed or have an incorrect dosage regime.

    Product
    BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-534-2013·2013-06-12

    TG United Recalls CPM PSE DM Drops Due to Underdosing

    TG United, Inc. is recalling CPM / PSE DM Drops because the products are underdosed or have an incorrect dosage regime.

    Product
    CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-532-2013·2013-06-12

    TG United Recalls Underdosed OTC Tablets Due to Manufacturing Deviations

    TG United, Inc. is recalling 386 bottles of TG 40PSE/400GFN tablets because they are underdosed or have an incorrect dosage regime.

    Product
    TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-542-2013·2013-06-12

    TG United Recalls Trigofen DM Drops Due to Underdosing

    TG United, Inc. is recalling 40,149 bottles of Trigofen DM Drops because the products are underdosed or have an incorrect dosage regime.

    Product
    Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30
    Category
    Drug
    Distribution
    5 states