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Granules Pharmaceuticals Inc.

Granules Pharmaceuticals Inc. Recalls

All product recalls associated with Granules Pharmaceuticals Inc..

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Recall Summary

Total Recalls

8

Past Year

6

Class I (Serious)

0

Most Recent

Aug 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 1–8 of 8 recalls

Dextroamphetamine Saccharate (Granules) – Impurity degradation risk (2025)

Failed Impurities/Degradation Specifications:

FDAAug 28, 2025Nationwide• Granules Pharmaceuticals Inc.

Dextroamphetamine Saccharate (Granules) – Impurity degradation risk (2025)

Failed Impurities/Degradation Specifications:

FDAAug 28, 2025Nationwide• Granules Pharmaceuticals Inc.

Dextroamphetamine Saccharate (Granules) – Impurity degradation risk (2025)

Failed Impurities/Degradation Specifications:

Low

FDAAug 28, 2025Nationwide• Granules Pharmaceuticals Inc.

Dextroamphetamine Saccharate (Granules) – Impurity degradation risk (2025)

Failed Impurities/Degradation Specifications:

FDAAug 28, 2025Nationwide• Granules Pharmaceuticals Inc.

Dextroamphetamine Saccharate (Granules) – Impurity degradation risk (2025)

Failed Impurities/Degradation Specifications:

FDAAug 28, 2025Nationwide• Granules Pharmaceuticals Inc.

Metoprolol Succinate Tablets 25mg (Granules) – Dissolution Specification Failure (2025)

Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.

Class IIModerate

FDAJun 24, 2025Nationwide• Granules Pharmaceuticals Inc.

Metformin ER Tablets 500mg (Granules) – foreign tablet found (2024)

Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.

Class IIModerate

FDADec 30, 2024IN, OH• Granules Pharmaceuticals Inc.

Metformin Hydrochloride Extended-Release 750mg (Granules) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAJul 3, 2020Nationwide• Granules Pharmaceuticals Inc