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# Breckenridge’s Solifenacin Succinate ANDA Withdrawn
- URL: https://www.fdaweb.com/breckenridges-solifenacin-succinate-anda-withdrawn/
- Published: 2021-08-27T12:00:00.000Z
- Updated: 2026-09-14T17:12:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150029

*Federal Register* notice: FDA has withdrawn the approval of a Breckenridge Pharmaceutical ANDA for solifenacin succinate tablets (5mg and 10mg) after the company requested such action. The company’s request is related to a 1/23/2020 field alert report that indicated the tablets may convert to solifenacin tartrate during manufacturing due to an interaction between solifenacin succinate and tartartic acid, which is an inactive ingredient in this drug product’s formulation. On 1/24/2020, Breckenridge issued a Class recall related to the matter. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-18586.pdf?ref=fdaweb.com).