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

10

Past Year

10

Class I (Serious)

0

Most Recent

Sep 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 1–10 of 10 recalls

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

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

Stay Informed

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

Recall Summary

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)

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)