Granules Pharmaceuticals Inc. Recalls

10 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Drug Recalls (10)

January 26, 2026
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151
Presence of Foreign Tablets/Capsules
Class II
August 28, 2025
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15
Failed Impurities/Degradation Specifications:
Class III
August 28, 2025
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 m
Failed Impurities/Degradation Specifications:
Class III
August 28, 2025
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10
Failed Impurities/Degradation Specifications:
Class III
August 28, 2025
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30
Failed Impurities/Degradation Specifications:
Class III
August 28, 2025
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20
Failed Impurities/Degradation Specifications:
Class III
June 24, 2025
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, H
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 II
December 30, 2024
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceutica
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 II
December 18, 2024
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Class II
July 31, 2024
Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Class II

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