VistaPharm, Inc. is recalling 3,084 bottles of Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored) because the product was incorrectly labeled. The packaging lists the medication as a Class III controlled substance when it is actually a Class II controlled substance, which is subject to stricter regulatory requirements. These 473 mL bottles were distributed nationwide to pharmacies and healthcare facilities.
The incorrect classification labeling could lead to the medication being handled, stored, or dispensed without the proper Class II security protocols. While the medication itself is safe for use as prescribed, the mislabeling represents a significant regulatory and tracking error for a high-potency controlled substance.
Drug recall baseline remedy
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.