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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

585

Past Year

Class I (Serious)

383

Most Recent

Oct 2025

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 361–380 of 585 recalls

Aripiprazole Tablets (Harvard Drug) – Dissolution Failure (2020)

Failed Dissolution Specifications: Out of specification for dissolution.

Class IIModerate

FDANov 18, 2020Nationwide• The Harvard Drug Group

Skytron, Div. The KMW Group, Inc: VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format...

VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a secondary display. Video would continue on the primary source device display

FDASep 11, 2020AZ, MI, MS +2 more• Skytron, Div. The KMW Group, Inc

Metformin Extended Release (Harvard Drug) – NDMA Impurity (2020)

CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.

Class II

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Moderate

FDAJun 12, 2020Nationwide• The Harvard Drug Group

Raw Macadamia Nuts (NOW) – Salmonella Contamination (2020)

Salmonella

The product tested positive for Salmonella enterica.

Class IHigh

FDAJun 12, 2020Nationwide• NOW Health Group Inc.

Doxycycline Tablets (Harvard Drug) – Failed Dissolution (2020)

Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.

Class IIModerate

FDAMay 22, 2020Nationwide• The Harvard Drug Group

Memantine Capsules (Harvard Drug) – Dissolution Failure (2020)

Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.

Class IIILow

FDAApr 24, 2020AL, FL, IA +3 more• The Harvard Drug Group

The Binding Site Group, Ltd.: The Optilite Clinical Chemistry Analyzer. IVD. Model Numb...

A software issue that may affect the analyzer's result accuracy.

FDAApr 9, 2020Nationwide• The Binding Site Group, Ltd.

Skytron, Div. The KMW Group, Inc: SkyVision SDS System - Video Integration Model: GC-SDS-BS...

Intermittent failure of a signal being sent to a monitor from the touch panel display causing the displaying monitor to go Blank and the touch panel to display a Blank image when reviewing the target display. If this issue were to happen during a case, cause increase risk to patient due to hospital losing the visual image.

FDAMar 10, 2020Nationwide• Skytron, Div. The KMW Group, Inc

Skytron, Div. The KMW Group, Inc: Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen...

Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.

FDAMar 5, 2020AZ, CO, GA +7 more• Skytron, Div. The KMW Group, Inc

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.

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 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

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

Memantine Hydrochloride Capsules (Harvard Drug) – Failed Dissolution (2019)

Failed Dissolution Specifications: High out of specification result observed at stability studies.

Class IIILow

FDADec 13, 2019Nationwide• The Harvard Drug Group

The Binding Site Group, Ltd.: Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vit...

It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.

FDANov 6, 2019CA, IN• The Binding Site Group, Ltd.

The Binding Site Group, Ltd.: Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT....

Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum. This could result in reporting abnormal (false positive) results, which may lead to unnecessary additional serological testing and a delay in treatment.

FDAOct 7, 2019AL, AZ, AR +17 more• The Binding Site Group, Ltd.

RESPIRATORY THERAPEUTICS GROUP LLC: RespVent Closed Suction System T-Piece Tracheostomy Adult...

It has been determined that some units of catheters were not tightly connected to the thumb port. This may result in the catheter disconnecting from the thumb port which could reduce the suction performance and make it difficult to remove from the patient's trachea.

FDAAug 19, 2019Nationwide• RESPIRATORY THERAPEUTICS GROUP LLC

Magnetic Trivets (Tristar) – Magnet Ingestion Risk (2019)

This recall involves Tristar Products magnetic trivets sold with Copper Chef 10-Piece Cerami-Tech Nonstick Cookware Sets and sold separately. The trivets attach to the bottom of hot metal cookware, allowing it to be placed on tables. The trivets have four magnets encased in silicone and come in copper, burgundy, blue, and black colors. Each set includes an 11 inch square pot with glass lid, steamer tray, fry basket, 11 inch fry pan with glass press, 9.5 inch square pot with glass lid, a cookbook, and two magnetic trivets.

CPSCJul 30, 2019Nationwide• Tianxi Holding Group Co Ltd., of China

The Binding Site Group, Ltd.: OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565

There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.

FDAJul 29, 2019AL, AZ, AR +25 more• The Binding Site Group, Ltd.

Travel Lite Sunnyside Lotion Wipe (LA FRESH) – Unapproved Sunscreen (2019)

Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites.

Class IIModerate

FDAJul 15, 2019Nationwide• La Fresh Group, Inc.