Urea — Class III drug recall D-1465-2016
Terminated recall by Exact-Rx Inc, reported 2016-08-31, distributed nationwide. Crystallization; complaints received by the manufacturer of crystals forming in product
| Recall number | D-1465-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exact-Rx Inc, Melville, NY, United States |
| Recall initiated | 2016-06-02 |
| Classified | 2016-08-23 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2018-06-14 |
| Distributed | Nationwide (US) |
| NDC | 42808-0200-05, 42808-0200-09 |
| Expiration dates | 2018-09 |
Product
Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY
Reason for recall
Crystallization; complaints received by the manufacturer of crystals forming in product
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1465-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.