Granules Pharmaceuticals Inc. recalled 11,909 bottles of Dextroamphetamine extended-release capsules on August 28, 2025. The recall stems from failure to meet impurities and degradation specifications. Healthcare providers and consumers must stop using the product immediately.
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, Extended-Release Capsules, 20 mg. The lot number is GPC250179A and it expires on June 22, 2027. The capsules were distributed nationwide in the USA.
The recall occurred due to the product failing impurities and degradation specifications. This issue could potentially affect the medication’s efficacy and safety.
No specific incidents or injuries have been reported in relation to this recall. The potential risks associated with impurities in medications can lead to serious health concerns.
Consumers and healthcare providers should stop using the product immediately. Contact Granules Pharmaceuticals Inc. or your healthcare provider for guidance on the recall.
For more information, contact Granules Pharmaceuticals Inc. via email or visit the FDA website for further details.
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