Remeven Cream — Class III drug recall D-1464-2016
Completed recall by Stratus Pharmaceuticals Inc, reported 2016-08-31, distributed nationwide. Crystallization; Complaints that cream appears to have crystallized
| Recall number | D-1464-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stratus Pharmaceuticals Inc, Miami, FL, United States |
| Recall initiated | 2016-05-26 |
| Classified | 2016-08-23 |
| Reported by FDA | 2016-08-31 |
| Distributed | Nationwide (US) |
| NDC | 58980-0680-50, 58980-0680-90 |
| Lot numbers | 58980-680-50, 58980-680-90, 8020, 8096, 8125, 8169, 8170 |
Product
Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL.
Reason for recall
Crystallization; Complaints that cream appears to have crystallized
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-1464-2016. 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.