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The Harvard Drug Group

The Harvard Drug Group Recalls

All product recalls associated with The Harvard Drug Group.

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Recall Summary

Total Recalls

1000

Past Year

591

Class I (Serious)

65

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 3341–3360 of 10393 recalls

Fexofenadine Tablets (Harvard Drug) – Impurity Concern (2021)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAAug 3, 2021Nationwide• The Harvard Drug Group

Flow Sensors (GE Healthcare) – Potential Anesthesia Leaks (2021)

Laceration Risk

The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.

FDAAug 2, 2021Nationwide• GE Healthcare, LLC

uEXPLORER PET/CT System (Shanghai United Imaging) – Scan Workflow Freeze (2021)

The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.

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FDAAug 2, 2021Nationwide• Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China

Flow Sensors (GE Healthcare) – Potential Anesthesia Leaks (2021)

Laceration Risk

The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.

FDAAug 2, 2021Nationwide• GE Healthcare, LLC

uMI 550 System (Shanghai United Imaging) – Scan Workflow Freeze (2021)

The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.

FDAAug 2, 2021Nationwide• Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China

Ingenia 1.5T MRI System (Philips) – Helium Gas Release Risk (2021)

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

FDAJul 30, 2021Nationwide• Philips North America Llc

Ingenia CX 3.0T MRI System (Philips) – Helium Gas Release Risk (2021)

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

FDAJul 30, 2021Nationwide• Philips North America Llc

Ingenia Elition X MRI System (Philips) – Helium Gas Release Risk (2021)

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

FDAJul 30, 2021Nationwide• Philips North America Llc

Ingenia 1.5T Evoluton (Philips) – Helium Gas Release Risk (2021)

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

FDAJul 30, 2021Nationwide• Philips North America Llc

Arjo Disposable Repositioning Sling (Antigua) – Trip Hazard (2021)

Sling loop straps on device pose a trip hazard.

FDAJul 30, 2021Nationwide• Antigua Carretera Sanchez Itabo, Haina Dominican Republic (the)

Ingenia 3.0T MRI System (Philips) – Helium Gas Release Risk (2021)

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

FDAJul 30, 2021Nationwide• Philips North America Llc

Ingenia Elition S MRI System (Philips) – Helium Gas Release Risk (2021)

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

FDAJul 30, 2021Nationwide• Philips North America Llc

Achieva 3.0T MRI System (Philips) – Helium Gas Release Risk (2021)

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

FDAJul 30, 2021Nationwide• Philips North America Llc

Children's Sleepwear Sets (SHEIN) – Burn Risk (2021)

This recall involves two styles of SHEIN branded children's sleepwear sets. The sleepwear sets are made of 97 percent polyester and 3 percent spandex. The sleepwear sets were sold in sizes "120, 130, 140, 150 and 160". The first sleepwear set is a children's two-piece, short-sleeved top and pant set in an allover multicolor plaid print. The second sleepwear set is a children's two-piece, long-sleeved top and pant set in an allover cartoon dinosaur print. Both sets were sold with a matching eye mask cover. The SKU associated with the recalled products are Sknight10190731477 and Sknight10191129405, which is printed on the hangtag inside the garment.

CPSCJul 29, 2021Nationwide• Puning Han Huini, of China

Alinity CRP Calibrator Kit (Sentinel) – Incorrect Labeling (2021)

Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully.

FDAJul 29, 2021Nationwide• Sentinel CH SpA Via Robert Koch

OASIS MRI System (Hitachi) – Rubber Material Undeclared (2021)

There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.

FDAJul 29, 2021Nationwide• Hitachi Healthcare Americas Corporation

ECHELON Oval MRI System (Hitachi) – Rubber Material Undeclared (2021)

There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.

FDAJul 29, 2021Nationwide• Hitachi Healthcare Americas Corporation

ECHELON MRI System (Hitachi) – Rubber Material Undeclared (2021)

There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.

FDAJul 29, 2021Nationwide• Hitachi Healthcare Americas Corporation

Entacapone Tablets (Harvard Drug) – Failed Dissolution (2021)

Failed Dissolution Specifications

Class IIModerate

FDAJul 29, 2021CO, FL, MO +1 more• The Harvard Drug Group

Ethosuximide Oral Solution (PAI Holdings) – CGMP Violation (2021)

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Class IIModerate

FDAJul 29, 2021Nationwide• PAI Holdings, LLC. dba Pharmaceutical Associates Inc