Sun Pharmaceutical Industries Inc. is recalling approximately 14,352 bottles of Esomeprazole Magnesium Delayed-Release Capsules (generic Nexium) because testing showed the medication was superpotent. The recall affects 90-count bottles of both 20mg and 40mg strengths. While no incidents or injuries have been reported, the medication contains more of the active ingredient than specified on the label.
Superpotent drugs deliver a higher dose of medication than intended by a physician. This increases the risk of side effects or unexpected drug interactions for patients taking the medication.
You have 2 options:
Manufactured by Ohm Laboratories Inc.; Distributed by Sun Pharmaceutical Industries, Inc.
Manufactured by Ohm Laboratories Inc.; Distributed by Sun Pharmaceutical Industries, Inc.
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.