Hazard

Underdosing recalls

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

What the numbers show

Total: 57
Critical: 2
Severe: 37
Most recent: 2025-06-18

Of the 57 underdosing recalls we have scored against our rubric, 2 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 37 (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 underdosing 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 57

SevereFDA (Devices)·Z-1972-2025·2025-06-18
BD Texium Closed System Drug Transfer Devices May Leak at Connector
BD Texium closed system drug transfer devices in multiple sizes may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, exposure to hazardous drugs, and underdosing.
Product
BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1970-2025·2025-06-18
Alaris Pump Infusion Sets may leak at male luer connections
BD Switzerland is recalling multiple Alaris Pump Infusion Set models worldwide due to potential leaks at the connection between the closed male luer component and needle-free connector, which could delay procedures, interrupt treatment, expose patients to hazardous drugs, or result in underdosing.
Product
Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1971-2025·2025-06-18
BD Texium Needle-Free Syringe Recalled for Potential Leakage at Luer Interface
BD Texium Needle-Free Syringes (multiple sizes) may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, medication underdosing, or exposure to hazardous drugs.
Product
BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1974-2025·2025-06-18
BD TEXIUM Closed Male Luer Devices Recalled for Leaking Interface Risk
BD TEXIUM closed male luer drug transfer devices may leak at the interface between the closed male luer component and the needle-free connector, potentially causing procedure delays, treatment interruptions, hazardous drug exposure, and medication underdosing.
Product
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1973-2025·2025-06-18
BD TEXIUM Closed Male Luer Drug Transfer Device Recall
BD TEXIUM Closed Male Luer devices may leak at the interface between the closed male luer component and needle-free connector. The leak could cause procedure delays, treatment interruptions, exposure to hazardous drugs, and underdosing of medication.
Product
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1441-2022·2022-07-27
Nexiva IV Catheter Stopcock May Leak During Infusion
Becton Dickinson is recalling specific lots of Nexiva IV catheters because the stopcock housing may leak, potentially interrupting treatment and exposing patients to infusate and biohazardous material.
Product
Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1437-2022·2022-07-27
BD Connecta Plus1 360 Infusion Connector: Potential Housing Leakage
Becton Dickinson is recalling certain BD Connecta Plus1 360 Blue Blend infusion connectors due to potential leakage at the housing stopcock that could interrupt treatment and expose patients to contamination and biohazardous material.
Product
BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1435-2022·2022-07-27
BD Connecta Stopcock Without Extension Tube Recalled for Potential Leakage Risk
Becton Dickinson & Company is recalling BD Connecta Stopcock units worldwide due to a potential housing leakage defect that could interrupt treatment or cause exposure to biohazardous material.
Product
BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2555-2021·2021-10-06
B. Braun Pump Set Cassette Leakage Risks Medication Delivery
B. Braun Medical recalls 13,320 pump sets due to cassette leakage that may delay medication administration and cause incomplete dosing or bloodstream infections.
Product
PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 480239
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2559-2021·2021-10-06
Outlook Pump Primary Administration Set Recalled for Potential Leakage and Medication Underdosing
B. Braun Medical is recalling the Outlook Pump Primary Administration Set due to potential leakage that could delay medication delivery and cause incomplete dosing of critical fluids in epidural administration.
Product
Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7453
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0038-2020·2019-10-02
Natpara Injection Recall Issued for Potential Needle Clogging and Underdosing
Shire is recalling Natpara (parathyroid hormone) for Injection due to a defective delivery system that may allow rubber stopper particles to clog the needle, leading to underdosing.
Product
Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA 68875-0205-02
Category
Drug
Distribution
0 states
CriticalFDA (Drugs)·D-0036-2020·2019-10-02
Natpara Injection Cartridges Recalled for Potential Needle Clogging
Shire is recalling Natpara injection cartridges because rubber stopper particles may clog the needle, potentially causing underdosing.
Product
Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0035-2020·2019-10-02
Natpara Injection Recall Due to Potential Needle Clogging and Underdosing
Shire is recalling Natpara (parathyroid hormone) injections because rubber stopper particles may clog the needle, potentially causing underdosing.
Product
Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0037-2020·2019-10-02
Natpara Injection Cartridges Recalled for Potential Needle Clogging
Shire is recalling Natpara (parathyroid hormone) injection cartridges because rubber stopper particles may clog the needle, leading to underdosing.
Product
Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0204-02
Category
Drug
Distribution
0 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-509-2013·2013-06-12
TG United Recalls Underdosed AMBI Antihistamine Nasal Decongestant Syrup
TG United, Inc. is recalling 355 bottles of AMBI antihistamine and nasal decongestant syrup due to CGMP deviations resulting in underdosed products.
Product
AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.
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
SevereFDA (Drugs)·D-519-2013·2013-06-12
TG United Recalls Brompheniramine/Pseudoephedrine DM Liquid Due to Underdosing
TG United, Inc. is recalling 22,721 bottles of Brompheniramine/Pseudoephedrine DM liquid because the product is underdosed or has an incorrect dosage regime.
Product
BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16
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-512-2013·2013-06-12
TG United Recalls Underdosed AMBI Cough Suppressant and Expectorant Bottles
TG United, Inc. is recalling specific lots of AMBI 40PSE/400GFN/20DM cough suppressant and expectorant bottles due to CGMP deviations resulting in underdosed products or incorrect dosage regimes.
Product
AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-518-2013·2013-06-12
TG United Recalls Dallergy Chewable Tablets Due to Underdosing
TG United, Inc. is recalling Dallergy Chewable Tablets because the products are underdosed or have an incorrect dosage regime.
Product
Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-521-2013·2013-06-12
TG United Recalls Cardec DM Drops Due to Underdosing
TG United, Inc. is recalling Cardec DM Drops because the products are underdosed or have an incorrect dosage regime.
Product
Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-523-2013·2013-06-12
TG United Recalls Maxifed-G Due to Underdosing and Incorrect Dosage
TG United, Inc. is recalling 1,623 bottles of Maxifed-G tablets because the products are underdosed or have an incorrect dosage regime.
Product
Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01
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-510-2013·2013-06-12
TG United Recalls AMBI Cough Syrup Due to Underdosing
TG United, Inc. is recalling 348 bottles of AMBI cough syrup because the product is underdosed or has an incorrect dosage regime.
Product
AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0230-16.
Category
Drug
Distribution
5 states