Lupin Somerset is recalling 4,716 bottles of Morphine Sulfate Extended-Release Tablets, 30 mg, because testing discovered an impurity called Morphinone Sulfate that exceeded safe limits. This prescription pain medication, manufactured by Novel Laboratories, Inc., is sold in 100-count bottles. Consumers who have these tablets should not stop taking them without first consulting a healthcare professional, as stopping abruptly can lead to withdrawal symptoms.
The presence of Morphinone Sulfate impurity at levels higher than specified can potentially increase the risk of adverse effects or reduce the safety and efficacy of the medication over time.
Contact healthcare provider or pharmacist and return for 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
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.