Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Bausch Health and its 25 subsidiaries with 203 drug applications, 118 510(k) clearances, 46 device recalls, 43 drug recalls, 2 OPDP letters and 2 complete response letters. The most recent is an OPDP letter dated Sep 9, 2025: Untitled letter: JUBLIA.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Bausch Health and its 25 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 9, 2025 | Untitled letter: JUBLIAOffice of Prescription Drug Promotion | OPDP letters |
| Aug 21, 2024 | Fraxel® FTX Laser SystemK242142 · GEX | 510(k) clearances |
| Dec 29, 2022 | CLEAR+BRILLIANT TOUCH® Laser SystemK223647 · GEX | 510(k) clearances |
| Mar 31, 2022 | Untitled letter: DUOBRIIOffice of Prescription Drug Promotion | OPDP letters |
| Sep 1, 2020 | VICTUS Femtosecond Laser PlatformK200724 · OOE | 510(k) clearances |
| Oct 18, 2019 | BIAFINE Topical CreamK190342 · FRO | 510(k) clearances |
| Jul 19, 2019 | Complete response letter, NDA 211039Approved | Complete response letters |
| May 1, 2019 | PowerX Lipo SystemK190555 · QPB | 510(k) clearances |
| May 1, 2019 | VASERlipo SystemK190551 · QPB | 510(k) clearances |
| Nov 20, 2018 | Complete response letter, NDA 210821Approved | Complete response letters |
| Aug 13, 2018 | BIAFINEK173549 · FRO | 510(k) clearances |
| Jan 8, 2018 | Thermage CPT System and AccessoriesK173759 · GEI | 510(k) clearances |
| Mar 20, 2014 | FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.Class II · Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained inc | Device recalls |
| Sep 20, 2013 | Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt. 3.5 g, Rx Only, Sample - not for sale, CORIA Laboratories, aClass III · Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration dat | Drug recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
