The Recall Desk

Hazard

Medication Error recalls

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

What the numbers show

Total
100
Critical
5
Severe
31
Most recent
2026-04-29

Of the 100 medication error recalls we have scored against our rubric, 5 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 31 (31%) 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 medication error 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.

51–75 of 100

  • SevereFDA (Devices)·Z-1786-2019·2019-06-26

    Monarch EndoTool IV Software Recalled for High Insulin Dosing Calculations

    Monarch Medical Technologies is recalling EndoTool IV software versions 1.8 through 1.10 because insulin dosing calculations were erroneously high.

    Product
    Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0992-2019·2019-03-13

    Apotex Recalls Out-of-Sequence Contraceptive Tablets

    Apotex Inc. is recalling specific lots of Drospirenone and Ethinyl Estradiol tablets because they may be missing or placed incorrectly in the blister pack.

    Product
    Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Pr
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0485-2019·2019-02-20

    Dr. Reddy's Recalls Levetiracetam Injection Due to Labeling Error

    Dr. Reddy's Laboratories is recalling Levetiracetam Injection bags because the primary label incorrectly identifies the product strength and sodium chloride concentration.

    Product
    LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2662-2018·2018-08-15

    Smiths Medical Recalls Medfusion Syringe Infusion Pumps with Defective Barrel Clamp Guides

    Smiths Medical ASD Inc. is recalling 276 Medfusion Syringe Infusion Pumps because a ridge in the Barrel Clamp Guide may cause spring slippage, preventing the pump from recognizing or correctly identifying loaded syringes.

    Product
    Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1136-2018·2018-03-28

    Smiths Medical Recalls Medfusion Syringe Pumps Due to Syringe Recognition Issues

    Smiths Medical is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, potentially preventing proper pump programming.

    Product
    Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2018·2017-12-13

    ICU Medical Recalls MedNet Medication Management Suite Software

    ICU Medical Inc is recalling MedNet 6.1 and 6.21 software because it may alter piggyback medication settings without user notice.

    Product
    ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet 6.1 c) 16037-64-03; MedNet 6.1 d) 16037-64-04; MedNet 6.21 The ICU Medical MedNet Medication Management Suite (MMS) is intended to faci
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1036-2017·2017-08-09

    Cyclobenzaprine Tablets Recalled for Incorrect Amantadine Labeling

    Apace KY LLC is recalling Cyclobenzaprine HCl 5 mg tablets because cartons were mislabeled as Amantadine HCl 100 mg capsules.

    Product
    Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0190-15
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0612-2017·2017-03-29

    Fougera Recalls Desonide Ointment Tubes Due to Labeling Mixup

    Fougera Pharmaceuticals is recalling 14,665 tubes of Desonide Ointment because unit boxes may contain tubes labeled as Ketoconazole Cream.

    Product
    Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0989-2017·2017-01-18

    Health Robotics Recalls i.v. Station Systems Due to Bag Mislabeling

    Health Robotics S.R.L. is recalling 121 i.v. Station and i.v. Station ONCO systems because a motor error caused misalignment and mislabeling of IV bags.

    Product
    i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0114-2017·2016-11-02

    Boehringer Ingelheim Recalls Dipyridamole Tablets Due to Foreign Tablet Presence

    Boehringer Ingelheim is recalling 6,400 bottles of 75 mg Dipyridamole tablets because 50 mg Persantine tablets were found inside the bottles.

    Product
    DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2790-2016·2016-09-21

    Hospira MedNet Software Recall for Incorrect Bolus Calculations

    Hospira is recalling MedNet 6.1 software used with SapphirePlus infusion pumps because it may calculate incorrect bolus amounts for drugs in Million Units.

    Product
    Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible co
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Drugs)·D-1481-2016·2016-09-14

    Amerisource Recalls Mispackaged Dextroamphetamine and Amphetamine Tablets

    Amerisource Health Services is recalling 221 cartons of mixed amphetamine tablets due to unit dose mispackaging, where blister cavities may contain more than one tablet.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 5 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2356-2016·2016-08-31

    Alere INRatio PT Monitoring Systems Recalled for Inaccurate INR Results

    Alere San Diego is voluntarily recalling INRatio PT Monitoring Systems because they may show lower INR results than central laboratory tests, potentially affecting warfarin therapy.

    Product
    Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2358-2016·2016-08-31

    Alere INRatio2 PT/INR Home Monitoring System Recalled for Inaccurate INR Results

    Alere San Diego is voluntarily recalling INRatio2 PT/INR Home Monitoring Systems because they may display inaccurate INR results compared to central laboratory tests.

    Product
    Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for qu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2362-2016·2016-08-31

    Alere INRatio PT/INR Test Strips Recalled for Inaccurate Results

    Alere San Diego is voluntarily recalling INRatio test strips because they may report inaccurate INR results, potentially affecting warfarin therapy.

    Product
    Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7 Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is app
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2355-2016·2016-08-31

    Alere INRatio PT/INR Monitoring Systems Recalled for Inaccurate INR Results

    Alere San Diego is voluntarily recalling INRatio PT/INR Monitoring Systems because they may report inaccurate INR values, potentially leading to incorrect anticoagulant dosing.

    Product
    INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRatio Prothrombin Time Monitoring System uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2359-2016·2016-08-31

    Alere INRatio 2 Home Monitor Recalled for Inaccurate INR Readings

    Alere San Diego is voluntarily recalling INRatio 2 home monitors because they may display inaccurate INR results compared to central laboratory tests.

    Product
    Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for quantitative d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2357-2016·2016-08-31

    Alere INRatio2 PT/INR Testing System Recalled for Inaccurate INR Results

    Alere San Diego is voluntarily recalling INRatio2 PT/INR Testing Systems because some patients showed significantly higher INR results in central laboratories than on the device.

    Product
    Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2016·2016-08-03

    Elekta Recalls MOSAIQ Oncology System Due to Potential Dosing Errors

    Elekta is recalling 383 units of the MOSAIQ Oncology Information System because a software issue may prevent order changes from saving, potentially resulting in incorrect chemotherapy doses.

    Product
    MOSAIQ Oncology Information System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0668-2016·2016-02-24

    Hospira Recalls Magnesium Sulfate Injection Bags Due to Incorrect Barcode Labeling

    Hospira is recalling 213,600 bags of Magnesium Sulfate in Water for Injection because the primary bag labeling may be mislabeled with a barcode that scans as heparin sodium.

    Product
    MAGNESIUM SULFATE IN WATER — MAGNESIUM SULFATE IN WATER (MAGNESIUM SULFATE IN WATER)
    Category
    Drug
    Distribution
    Distributed nationwide