The Harvard Drug Group LLC Recalls

All product recalls associated with The Harvard Drug Group LLC.

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Recall Summary

Total Recalls

14

Past Year

14

Class I (Serious)

0

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 1–14 of 14 recalls

Gabapentin Capsules (Harvard Drug) – impurity specification failure (2025)

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

Class IIModerate

FDAOct 10, 2025Nationwide• The Harvard Drug Group LLC

Gabapentin Capsules (Harvard Drug) – impurity specification failure (2025)

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

Class IIModerate

FDAOct 10, 2025Nationwide• The Harvard Drug Group LLC

ChlorproMAZINE Hydrochloride Tablets (Major Pharmaceuticals) – N-Nitroso impurity (2025)

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

Class IIModerate

FDASep 12, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Sulfamethoxazole and Trimethoprim (Major) – Foreign substance packaging (2025)

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDASep 2, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Carvedilol Tablets (Harvard Drug Group) - Impurity Concern (2025)

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Class IIModerate

FDAAug 20, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Gabapentin Capsules 100mg (Harvard Drug) – Defective Container (2025)

Defective container; blister packaging inadequately sealed.

Class IIModerate

FDAJun 19, 2025Nationwide• The Harvard Drug Group LLC

Gabapentin Capsules 100mg (Harvard Drug) – Defective Container (2025)

Defective container; blister packaging inadequately sealed.

Class IIModerate

FDAJun 19, 2025Nationwide• The Harvard Drug Group LLC

ChlorproMAZINE Tablets (Harvard Drug) – Nitrosamine Impurity (2025)

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Class IIModerate

FDAApr 14, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Tolterodine Tartrate (Major Pharmaceuticals) – Dissolution Failure (2025)

Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

Class IIILow

FDAMar 4, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Potassium Chloride Tablets (Harvard Drug) – Dissolution Failure (2025)

Failed Dissolution Specifications.

Class IIModerate

FDAJan 30, 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

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 1mg (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)

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

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The Harvard Drug Group LLC Recalls

Recall Summary

Gabapentin Capsules (Harvard Drug) – impurity specification failure (2025)

Gabapentin Capsules (Harvard Drug) – impurity specification failure (2025)

ChlorproMAZINE Hydrochloride Tablets (Major Pharmaceuticals) – N-Nitroso impurity (2025)

Sulfamethoxazole and Trimethoprim (Major) – Foreign substance packaging (2025)

Carvedilol Tablets (Harvard Drug Group) - Impurity Concern (2025)

Gabapentin Capsules 100mg (Harvard Drug) – Defective Container (2025)

Gabapentin Capsules 100mg (Harvard Drug) – Defective Container (2025)

ChlorproMAZINE Tablets (Harvard Drug) – Nitrosamine Impurity (2025)

Tolterodine Tartrate (Major Pharmaceuticals) – Dissolution Failure (2025)

Potassium Chloride Tablets (Harvard Drug) – Dissolution Failure (2025)

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

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

Lorazepam Tablets 1mg (Major) – Potency Concern (2025)

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