Granules India’s wholly owned foreign subsidiary -- Granules Pharmaceuticals, Inc., is recalling over 49,000 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, extended-release capsules in multiple strengths due to failed impurities/degradation specifications.
The US-based arm of the company issued the Class III recall on August 28, 2025. As per the USFDA, a Class III recall is initiated in a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
