Remeven Cream Recall: Crystallization Issue
Stratus Pharmaceuticals recalls Remeven Cream due to crystallization. Check lot numbers and expiration dates for affected 5 oz and 9 oz tubes.
Recall notice
Crystallization; Complaints that cream appears to have crystallized
Contact the company
What happened, in plain English
Stratus Pharmaceuticals Inc is recalling specific lots of Remeven Cream, a prescription medication containing 50% urea, because the cream has been reported to crystallize. The recall covers both 5.0 oz (142 g) and 9.0 oz (255 g) tubes distributed nationwide and in Puerto Rico. The record does not specify any physical injury risk or provide a remedy for consumers. Read more at govinfonow.com/recall/42601-remeven-cream-recall-crystallization-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/42601-remeven-cream-recall-crystallization-issue · Updated October 9, 2026 · FDA enforcement record: FDA #D-1464-2016
Cite this page
“Remeven Cream Recall: Crystallization Issue.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42601-remeven-cream-recall-crystallization-issue. Based on FDA recall #D-1464-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1464-2016%22&limit=1).
Why it’s dangerous
The hazard is described as crystallization within the cream base. The record does not explain how this physical change affects the product's safety or efficacy, nor does it list any associated injuries or health risks.
Who’s affected
Consumers who purchased Remeven Cream from pharmacies across the United States and Puerto Rico between the manufacturing dates and May 26, 2016. Patients using this prescription urea cream are the primary group affected by the potential quality issue.
How to tell if you have this one
Check your Remeven Cream tubes for the following details: Size (5.0 oz/142 g or 9.0 oz/255 g), NDC numbers (58980-680-50 or 58980-680-90), and specific lot numbers with expiration dates. Affected lots include: 8020 (Exp 02/17), 8096 (Exp 07/18), 8125 (Exp 08/18), 8169 (Exp 10/18) for the 5 oz size; and 8020 (Exp 02/17), 8125 (Exp 08/18), 8170 (Exp 10/18) for the 9 oz size.
- Brand
Remeven- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and PR” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1464-2016 (May 26, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1464-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.