Class II — Reckitt Benckiser LLC
| Recalling firm | Reckitt Benckiser LLC |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life |
| Product | Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease). |
| Quantity | 34 cartons/12 condoms each (408 condoms total) |
| Distribution | US in the states of NY |
| Initiated | 2018-08-06 |
| Classified | 2018-10-09 |
| Terminated | 2019-11-12 |
| Recall number | Z-0091-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Reckitt Benckiser LLC (Z-0091-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80939/
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