Granules Pharmaceuticals Inc. recalled 11,895 bottles of extended-release capsules on August 28, 2025. The capsules failed impurities and degradation specifications. Consumers should stop using the product immediately, as it could pose health risks.
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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The recalled product is Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, 10 mg, 100 capsules per bottle. The recall affects lot number GPC250159A with an expiration date of June 22, 2027. It was distributed nationwide in the USA.
The product failed to meet impurities and degradation specifications set by regulatory standards. This failure can lead to potential health risks, including degradation of the medication's effectiveness.
No specific incidents or injuries related to this recall have been reported at this time. The recall is classified as high risk due to the potential health implications.
Consumers and healthcare providers should stop using the recalled capsules immediately. Contact Granules Pharmaceuticals Inc. or your healthcare provider for further guidance.
For more information, reach Granules Pharmaceuticals Inc. via email. Additional details can be found on the FDA's recall page.
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