Consumer health companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 3 companies' records, each linked to the record.
As of Nov 13, 2026, FDA's public records list Reckitt and its 3 subsidiaries with 25 510(k) clearances, 11 drug recalls, 6 drug applications, 5 device recalls and 1 complete response letter. The most recent is a 510(k) clearance dated Feb 28, 2025: Durex Polyisoprene Condom.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Reckitt and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Feb 28, 2025 | Durex Polyisoprene CondomK241617 · MOL | 510(k) clearances |
| Jul 26, 2024 | Complete response letter, NDA 217338Unapproved | Complete response letters |
| Aug 29, 2023 | Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count plastic jar, further packaged in case of 6 jars per casClass III · Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging. | Drug recalls |
| Jun 20, 2023 | Belle SensilubeK230781 · NUC | 510(k) clearances |
| Mar 7, 2023 | Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & MineK213892 · NUC | 510(k) clearances |
| Nov 7, 2022 | Durex Patronus CloseFit, Durex Patronus RegularK220489 · HIS | 510(k) clearances |
| Oct 12, 2022 | Durex Penck III RegularK222068 · HIS | 510(k) clearances |
| May 11, 2022 | Durex Condom with BenzocaineK211152 · HIS | 510(k) clearances |
| Mar 1, 2022 | Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play StrawberryK213400 · NUC | 510(k) clearances |
| Feb 17, 2022 | Durex Patronus WideK213647 · HIS | 510(k) clearances |
| Dec 19, 2018 | Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98Class II · Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. | Device recalls |
| Dec 19, 2018 | Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 0234Class II · Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. | Device recalls |
| Aug 6, 2018 | Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposeClass II · Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifica | Device recalls |
| Jul 23, 2018 | Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex SyntClass II · The products failed the filed specification of 1.0kPa for Burst Pressure. | Device recalls |
| Nov 22, 2016 | Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms Class II · Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling assoc | Device 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
