Granules Pharmaceuticals recalls

Granules Pharmaceuticals has 11 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 11 Feb 2026. 8 are still ongoing. 6 were reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls11since 2020

Last 12 months6reported

Class I00% of total

Ongoing8latest 11 Feb 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 2Jan '25 0 0 0Apr 0 0 1Jul 0 0 5Oct 0 0 0Jan '26 1 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 6 55%Class III 5 45%

Why granules pharmaceuticals is recalled

Product types

Brands

By year

202619%
2025873%
202419%
202019%

Ongoing granules pharmaceuticals recalls

8 active

Reported	Class	Recall	Company	Reason	Where
11 Feb 2026Drug	CLASS II	Trazodone Hydrochloride, USP, 50 mg recalled by Granules PharmaceuticalsTrazodone Hydrochloride	Granules Pharmaceuticals	Other	Nationwide
1 Oct 2025Drug	CLASS III	Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Granules Pharmaceuticals	Potency & Assay	Nationwide
1 Oct 2025Drug	CLASS III	Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Granules Pharmaceuticals	Potency & Assay	Nationwide
1 Oct 2025Drug	CLASS III	Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Granules Pharmaceuticals	Potency & Assay	Nationwide
1 Oct 2025Drug	CLASS III	Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Granules Pharmaceuticals	Potency & Assay	Nationwide
1 Oct 2025Drug	CLASS III	Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Granules Pharmaceuticals	Potency & Assay	Nationwide

All granules pharmaceuticals recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
11 Feb 2026Drug	CLASS II	Trazodone Hydrochloride, USP, 50 mg recalled by Granules PharmaceuticalsTrazodone Hydrochloride	Granules Pharmaceuticals	Other	Nationwide
1 Oct 2025Drug	CLASS III	Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Granules Pharmaceuticals	Potency & Assay	Nationwide
1 Oct 2025Drug	CLASS III	Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Granules Pharmaceuticals	Potency & Assay	Nationwide
1 Oct 2025Drug	CLASS III	Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Granules Pharmaceuticals	Potency & Assay	Nationwide
1 Oct 2025Drug	CLASS III	Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Granules Pharmaceuticals	Potency & Assay	Nationwide
1 Oct 2025Drug	CLASS III	Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Granules Pharmaceuticals	Potency & Assay	Nationwide
9 Jul 2025Drug	CLASS II	Metoprolol Succinate Extended-Release Tablets, USP, 25 mg recalledMetoprolol Succinate	Granules Pharmaceuticals	Potency & Assay	Nationwide
15 Jan 2025Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg recalledMetformin Er 500 Mg	Granules Pharmaceuticals	Other	OH
15 Jan 2025Drug	CLASS II	Colchicine Capsules 6 mg recalled by Granules PharmaceuticalsColchicine	Granules Pharmaceuticals	Potency & Assay	Nationwide
14 Aug 2024Drug	CLASS II	Gabapentin Tablets, USP, 600 mg recalled by Granules PharmaceuticalsGabapentin	Granules Pharmaceuticals	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.