ANI Pharmaceuticals, Inc. has recalled approximately 93,912 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules (Mixed Salts of A Single-Entity Amphetamine Product) in multiple strengths. These prescription medications, manufactured for Amerigen Pharmaceuticals, were labeled with a 24-month expiration date when they should have only been dated for 18 months. This labeling error means the medication may be used past its verified shelf life, potentially affecting the drug's potency or stability.
The product was labeled with an expiration date 6 months longer than supported by stability data, which could lead to consumers taking medication that has degraded or lost its intended effectiveness.
Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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