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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

589

Class I (Serious)

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 4501–4520 of 10393 recalls

Quetiapine Extended-Release 300mg (Harvard) – Incorrect Insert (2020)

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

Class IIILow

FDAFeb 27, 2020Nationwide• The Harvard Drug Group

Quetiapine Extended-Release 150mg (Harvard) – Incorrect Insert (2020)

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

Class IIILow

FDAFeb 27, 2020Nationwide• The Harvard Drug Group

Quetiapine Extended-Release 50mg (Harvard) – Incorrect Insert (2020)

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

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Class IIILow

FDAFeb 27, 2020Nationwide• The Harvard Drug Group

Atellica CH 930 Analyzer (Siemens) – software editing (2020)

Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.

Low

FDAFeb 27, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

uDR 596i X-Ray Imaging System (Shanghai United Imaging) – Incorrect Patient Interface (2020)

Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care. When the image is acquired with the wrong reference position, clinical diagnostic requirements cannot be met.T2. Where image stitching is used, the left and right tag information may be lost. When these problems are encountered, an additional exposure is needed and the patient will receive more radiation.

Moderate

FDAFeb 27, 2020Nationwide• Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China

Quetiapine Extended-Release 200mg (Harvard) – Incorrect Insert (2020)

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

Class IIILow

FDAFeb 27, 2020Nationwide• The Harvard Drug Group

HeartStart MRx Defibrillators (Philips) – Internal Damage Risk (2020)

Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after having been dropped or subjected to a severe mechanical shock, even though the device did not have visible external damage or the Ready for Use ( RFU ) indicator on the unit did not immediately indicate a problem. One of these reports involved a death of a patient who could not be resuscitated.

Very High

FDAFeb 26, 2020Nationwide• Philips North America, LLC

L-Cysteine HCl Anhydrous (Cj Haide) – metal contamination (2020)

Foreign material, metal

Class IIModerate

FDAFeb 21, 2020CA, CT, FL +1 more• Cj Haide (Ningbo) Biotech Co., Ltd

RayStation 9B (RaySearch) – Tabletop Position Error (2020)

There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.

Moderate

FDAFeb 20, 2020TN• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

Expression MR400 Monitor (Philips) – Oxygen Sensor Calibration (2020)

Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, the instructions for performing the O2 sensor calibration are incorrect for customers performing this task with an MR400 device with software revisions: 01 .03.00, 01.04.00, 01 .05.00 and 01 .07.00

Moderate

FDAFeb 20, 2020Nationwide• Philips North America, LLC