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.
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
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 recalled capsules failed to meet impurities and degradation specifications. This class III recall indicates a high hazard level, potentially affecting patient safety.
No specific incidents or injuries have been reported at this time. The recall is precautionary based on testing results.
Stop using the recalled capsules immediately. Contact Granules Pharmaceuticals Inc. or your healthcare provider for guidance on next steps.
For further assistance, reach Granules Pharmaceuticals at their email provided in recall notifications. Additional information can be found on the FDA website.
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