Granules Pharmaceuticals recalled 11,928 bottles of amphetamine capsules on August 28, 2025. The recall follows failure to meet impurities and degradation specifications. Consumers should stop using the product immediately and contact their healthcare providers.
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 recall involves Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate, 30 mg, 100 capsules per bottle. The affected lot number is GPC250181A, with an expiration date of June 19, 2027. The product was distributed nationwide in the USA.
The capsules failed impurities and degradation specifications, posing a potential health risk. Impurities in medications can affect their efficacy and safety.
No specific incidents or injuries have been reported in connection with this recall. The recall was classified as Class III, indicating a possible health hazard but not likely to cause serious adverse health consequences.
Stop using the recalled product immediately. Contact Granules Pharmaceuticals Inc. or your healthcare provider for further guidance. Consumers can reach out via email for assistance.
For questions regarding the recall, consumers can contact Granules Pharmaceuticals Inc. directly. Additional information is available on the FDA website.
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