Granules Pharmaceuticals recalls
6 official recalls and safety alerts involving Granules Pharmaceuticals since 2024-08, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Granules Pharmaceuticals or the relevant agency.
- 2026-02-11
US- 2025-10-01
- US
Granules Pharmaceuticals Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate,…
Failed Impurities/Degradation Specifications:
- 2025-07-09
- US
Granules Pharmaceuticals Inc. recalls Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle,…
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
- 2025-01-15
- US
Granules Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India…
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.
- US
Granules Pharmaceuticals Inc. recalls Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC…
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
- 2024-08-14
- US
Granules Pharmaceuticals Inc. recalls Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India,…
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets