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MAJOR PHARMACEUTICALS

MAJOR PHARMACEUTICALS Recalls

All product recalls associated with MAJOR PHARMACEUTICALS.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

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 21–25 of 25 recalls

Doxycycline Hyclate Tablets 100mg (Major Pharmaceuticals) – Dissolution Failure (2018)

Failed Dissolution Specifications

Class IIModerate

FDAJul 30, 2018Nationwide• MAJOR PHARMACEUTICALS

Valsartan Tablets 160mg (Major Pharmaceuticals) – Carcinogen Impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAJul 18, 2018Nationwide• MAJOR PHARMACEUTICALS

Valsartan Tablets (Major Pharmaceuticals) – Carcinogen Impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class II

Page 2 of 2Next

Moderate

FDAJul 18, 2018Nationwide• MAJOR PHARMACEUTICALS

Enalapril Maleate 2.5mg Tablets (Major Pharmaceuticals) – impurity specifications (2018)

Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.

Class IIILow

FDAJun 26, 2018Nationwide• MAJOR PHARMACEUTICALS

Enalapril Maleate 5mg Tablets (Major Pharmaceuticals) – impurity specifications (2018)

Class IIILow

FDAJun 26, 2018Nationwide• MAJOR PHARMACEUTICALS