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# Ultram Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/ultram-not-withdrawn-due-to-safety-efficacy/
- Published: 2023-10-04T12:00:00.000Z
- Updated: 2026-09-14T19:00:23.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155486

*Federal Register* notice: FDA has determined that Janssen Pharmaceuticals’ Ultram (tramadol hydrochloride) tablets, 50 mg, was not withdrawn from sale for safety or effectiveness reasons. The determination means the agency can continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Ultram is indicated for managing pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-10-04/pdf/2023-21990.pdf?ref=fdaweb.com).