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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

Past Year

Class I (Serious)

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 69 recalls

Phenytoin Oral Suspension (Major) – content uniformity issue (2023)

Failed Content Uniformity Specifications

Class IHigh

FDAOct 23, 2023Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Tramadol Hydrochloride Tablets (Harvard Drug) – Packaging Defect (2023)

Packaging defect: blister packaging inadequately sealed.

Class IIModerate

FDAJun 16, 2023Nationwide• The Harvard Drug Group

Ziprasidone Hydrochloride Capsules (Harvard Drug Group) – Label Mix-up (2023)

Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.

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Class IHigh

FDAMay 31, 2023Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Gabapentin Tablets (Harvard Drug) – Product Mixup (2023)

Product mixup: one foreign tablet found in product.

Class IIILow

FDAApr 24, 2023Nationwide• The Harvard Drug Group

Carbidopa-Levodopa Tablets (Harvard Drug Group) – packaging defect (2023)

Packaging defect: observed packaging defect, blister packaging inadequately sealed.

Class IIModerate

FDAFeb 23, 2023Nationwide• The Harvard Drug Group

Paliperidone Tablets (Harvard Drug Group) – dissolution failure (2022)

Failed Dissolution Specifications

Class IIModerate

FDAFeb 28, 2022Nationwide• The Harvard Drug Group

hydrALAZINE HCl Tablets (Harvard Drug Group) – Impurity Specification Failure (2022)

Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.

Class IIModerate

FDAFeb 24, 2022Nationwide• The Harvard Drug Group

Carbamazepine Tablets (Harvard Drug) – Dissolution Failure (2021)

Failed Dissolution Specifications

Class IIModerate

FDAAug 6, 2021NC• The Harvard Drug Group

Fexofenadine Tablets (Harvard Drug) – Impurity Concern (2021)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAAug 3, 2021Nationwide• The Harvard Drug Group

Entacapone Tablets (Harvard Drug) – Failed Dissolution (2021)

Failed Dissolution Specifications

Class IIModerate

FDAJul 29, 2021CO, FL, MO +1 more• The Harvard Drug Group

Nifedipine Extended-Release Tablets (Harvard Drug) – Failed Dissolution (2021)

Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.

Class IIModerate

FDAJul 2, 2021IN, NJ, OH• The Harvard Drug Group

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

Failed Dissolution Specifications: Out of specification for dissolution.

Class IIModerate

FDANov 18, 2020Nationwide• The Harvard Drug Group

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

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

Class IIModerate

FDAJun 12, 2020Nationwide• The Harvard Drug Group

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

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

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.

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