Granules Pharmaceuticals recalled 11,895 bottles of an extended-release amphetamine product due to failed impurities and degradation specifications. The recall is active nationwide in the United States. The FDA notice lists a high hazard level and urges stop-use and contact with the company or a healthcare provider.
Failed Impurities/Degradation Specifications:
Consumers and healthcare providers should stop using this product immediately. Contact Granules Pharmaceuticals Inc. or your healthcare provider for guidance. Notification method: E-Mail
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This is a prescription extended-release amphetamine product used for ADHD and narcolepsy in adults and certain patients. It is manufactured by a US facility.
The defect relates to impurities/degradation specifications which could affect safety, but specific health effects are not detailed in the release.
This recall is not described as part of a broader industry pattern.
No injuries reported yet; immediate stop-use is required to prevent potential risk and ensure patient safety.
FDA recall page D-0670-2025 and manufacturer communications
Remedies and refunds typically processed within several weeks to a few months depending on manufacturer policy
Keep recall notices, bottle labels, and communications with the manufacturer; document any adverse events.
Brand: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate. Manufacturer: Granules Pharmaceuticals Inc., Chantilly, VA 20151. NDC: 70010-030-01. Quantity: 11,895 bottles. Sold nationwide in the USA. Date codes/lot: lot#: GPC250159A. Expiration: 06-22-2027. Reminder: Rx only.
No specific injuries or adverse events are reported in the available notice.
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