Teva Pharmaceuticals USA has issued a voluntary recall of 13,715 bottles of Omega-3-Acid Ethyl Esters Capsules USP (1 gram) in 120-count bottles. This prescription medication is being recalled because the active pharmaceutical ingredient (API) used in manufacturing did not receive necessary regulatory approval before being released for sale. This recall affects one specific lot of the medication that was distributed throughout the United States. Consumers should consult their healthcare provider or pharmacist regarding this recall and to arrange for a replacement or refund.
The product was manufactured using materials that did not undergo the required regulatory review and approval process, which is designed to ensure the quality, safety, and efficacy of the medication. While no specific injuries or adverse health effects have been reported to date, the use of unapproved ingredients means the safety and quality of the final product cannot be fully guaranteed.
Return for refund and healthcare consultation
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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.