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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Recalls

All product recalls associated with The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories.

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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 21–40 of 585 recalls

Lorazepam Tablets 0.5mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Lorazepam Tablets 2mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Duloxetine Capsules (Harvard Drug Group) – Nitrosamine Impurity (2025)

123 4...30

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CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

Class IIModerate

FDAJan 13, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Guaifenesin Dextromethorphan Syrup (Harvard Drug Group) – Specification Failure (2024)

Failed Impurity/Degradation Specifications

Class IIModerate

FDANov 7, 2024Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Hydralazine HCl Tablets (Major Pharmaceuticals) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

Class IIILow

FDANov 5, 2024Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Berkley Jensen Gazebos (BJ's Wholesale) – Injury Risk (2024)

This recall involves Berkley Jensen branded cedar hard-topped gazebos with model numbers A102008010, A102008100, A102011920, and A102011902. The gazebos measure about 10 feet by 12 feet, or 12 feet by 14 feet. They were sold in copper color, which may appear brown, or black; and with or without netting panels and tie-back bands. Only these models sold during the dates identified below are included in this recall.

High

CPSCAug 15, 2024Nationwide• Lypometal Sdn. Bhd., of Malaysia (Sunjoy Group)

Venlafaxine Hydrochloride (Major Pharmaceuticals) – Dissolution Failure (2024)

Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.

Class IIModerate

FDAJun 18, 2024Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Garden Veggie Straws Sea Salt (Hain Celestial) – Undeclared Milk (2024)

Undeclared Milk

Undeclared milk

Class IHigh

FDAMar 29, 2024AR, GA, IN +7 more• THE HAIN CELESTIAL GROUP INC

HydrALAZINE Tablets (Harvard Drug) – Impurity Concern (2024)

an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.

Class IIModerate

FDAFeb 9, 2024Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories