--- title: "Granules Pharmaceuticals Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Granules Pharmaceuticals Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/granules-pharmaceuticals-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Granules Pharmaceuticals Inc. recall records **7** reported ongoing 10 records in this archive. Latest source date Jan 26, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jan 26, 2026 FDA drug enforcement ### [Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals In...](https://isitonrecall.com/recall/fda-drug-d-0305-2026-trazodone-hydrochloride-usp-50-mg-100-count-bottle-rx-only-manufactured-by-granules-india-limited-hy/) Presence of Foreign Tablets/Capsules Class II Reported ongoing Distribution: US Nationwide. [Official source for Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India L...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0305-2026%22) Aug 28, 2025 FDA drug enforcement ### [Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Am...](https://isitonrecall.com/recall/fda-drug-d-0669-2025-dextroamphetamine-saccharate-amphetamine-aspartate-monohydrate-dextroamphetamine-sulfate-and-ampheta/) Failed Impurities/Degradation Specifications: Class III Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Am...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0669-2025%22) Aug 28, 2025 FDA drug enforcement ### [Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Am...](https://isitonrecall.com/recall/fda-drug-d-0670-2025-dextroamphetamine-saccharate-amphetamine-aspartate-monohydrate-dextroamphetamine-sulfate-and-ampheta/) Failed Impurities/Degradation Specifications: Class III Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Am...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0670-2025%22) Aug 28, 2025 FDA drug enforcement ### [Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Am...](https://isitonrecall.com/recall/fda-drug-d-0671-2025-dextroamphetamine-saccharate-amphetamine-aspartate-monohydrate-dextroamphetamine-sulfate-and-ampheta/) Failed Impurities/Degradation Specifications: Class III Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Am...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0671-2025%22) Aug 28, 2025 FDA drug enforcement ### [Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Am...](https://isitonrecall.com/recall/fda-drug-d-0672-2025-dextroamphetamine-saccharate-amphetamine-aspartate-monohydrate-dextroamphetamine-sulfate-and-ampheta/) Failed Impurities/Degradation Specifications: Class III Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Am...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0672-2025%22) Aug 28, 2025 FDA drug enforcement ### [Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Am...](https://isitonrecall.com/recall/fda-drug-d-0673-2025-dextroamphetamine-saccharate-amphetamine-aspartate-monohydrate-dextroamphetamine-sulfate-and-ampheta/) Failed Impurities/Degradation Specifications: Class III Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Am...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0673-2025%22) Jun 24, 2025 FDA drug enforcement ### [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: Gr...](https://isitonrecall.com/recall/fda-drug-d-0510-2025-metoprolol-succinate-extended-release-tablets-usp-25-mg-packaged-in-a-100-count-bottle-ndc-70010-780/) 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 Reported ongoing Distribution: Nationwide in the USA. [Official source for Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 7...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0510-2025%22) Dec 30, 2024 FDA drug enforcement ### [Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for:...](https://isitonrecall.com/recall/fda-drug-d-0192-2025-metformin-hydrochloride-extended-release-tablets-usp-500-mg-1000-count-bottles-rx-only-manufactured/) 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 Reported terminated Distribution: Distributor in OH. [Official source for Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manuf...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0192-2025%22) Dec 18, 2024 FDA drug enforcement ### [Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03](https://isitonrecall.com/recall/fda-drug-d-0187-2025-colchicine-capsules-0-6-mg-30-count-bottles-rx-only-manufactured-by-granules-pharmaceuticals-inc-cha/) Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles. Class II Reported terminated Distribution: Nationwide within the United States [Official source for Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0187-2025%22) Jul 31, 2024 FDA drug enforcement ### [Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., C...](https://isitonrecall.com/recall/fda-drug-d-0634-2024-gabapentin-tablets-usp-600-mg-500-count-bottles-rx-only-manufactured-by-granules-india-limited-hyder/) Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets Class II Reported terminated Distribution: Nationwide in the USA [Official source for Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limi...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0634-2024%22) ## Reasons in these listed records - Presence of Foreign Tablets/Capsules - Failed Impurities/Degradation Specifications: - Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term. - 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. These examples come from this result page and are not a ranking of every recall reason. ## Checking Granules Pharmaceuticals Inc. ### Is there a recall on granules pharmaceuticals inc. right now? This archive contains 10 records, including 7 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Granules Pharmaceuticals Inc.](https://isitonrecall.com/check/?q=Granules%20Pharmaceuticals%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)