Granules Pharmaceuticals Recalls Dextroamphetamine Capsules Over Contamination Risk
Granules Pharmaceuticals Inc. recalled 9,917 bottles of Dextroamphetamine extended-release capsules on August 28, 2025. The product failed impurities and degradation specifications, posing potential health risks. Consumers should stop using the capsules immediately and consult healthcare providers for guidance.
Product Details
Granules Pharmaceuticals manufactured 15 mg extended-release capsules of Dextroamphetamine, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate. The product, identified by NDC 70010-031-01, was distributed nationwide in the USA.
The Hazard
The recalled capsules failed to meet impurities and degradation specifications. This class III recall indicates a high hazard level, potentially affecting patient safety.
Reported Incidents
No specific incidents or injuries have been reported at this time. The recall is precautionary based on testing results.
What to Do
Stop using the recalled capsules immediately. Contact Granules Pharmaceuticals Inc. or your healthcare provider for guidance on next steps.
Contact Information
For further assistance, reach Granules Pharmaceuticals at their email provided in recall notifications. Additional information can be found on the FDA website.