Exact-Rx Urea Cream Recall: Crystallization Hazard
Exact-Rx Inc recalls specific lots of 50% Urea Cream due to crystallization. Check your NDC and lot numbers for details on affected products.
Lower-risk recall
Crystallization; complaints received by the manufacturer of crystals forming in product
Contact the company
What happened, in plain English
Exact-Rx Inc is recalling Urea (50% Urea in a Cream Base) because complaints were received about crystals forming in the product. The recall covers two package sizes: 5 oz tubes with NDC 42808-0200-05 and 9 oz tubes with NDC 42808-0200-09. This is a Class III recall, which typically indicates a hazard that is unlikely to cause serious adverse health consequences but may involve minor issues or regulatory violations. Read more at govinfonow.com/recall/42593-exact-rx-urea-cream-recall-crystallization-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/42593-exact-rx-urea-cream-recall-crystallization-hazard · Updated October 9, 2026 · FDA enforcement record: FDA #D-1465-2016
Cite this page
“Exact-Rx Urea Cream Recall: Crystallization Hazard.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42593-exact-rx-urea-cream-recall-crystallization-hazard. Based on FDA recall #D-1465-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1465-2016%22&limit=1).
Why it’s dangerous
The manufacturer received complaints indicating that crystals were forming within the cream base. While the record does not specify a direct injury mechanism, crystallization can alter the product's consistency and potentially affect its application or efficacy as a topical medication.
Who’s affected
Consumers who purchased Exact-Rx Urea Cream nationwide between the manufacture date and September 2018. Individuals using this prescription-only medication for skin conditions are the primary group affected by the potential texture changes.
How to tell if you have this one
Check your tube for the following details: Brand 'Exact-Rx', NDC numbers 42808-0200-05 (5 oz/142 g) or 42808-0200-09 (9 oz/225 g), and Lot number 8160. The expiration date on these products is September 2018.
- Brand
Exact-Rx- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How can I identify if I have the recalled product?
Look for NDC 42808-0200-05 (5 oz) or NDC 42808-0200-09 (9 oz), manufactured by Exact-Rx Inc. in Melville, NY.
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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-1465-2016 (June 2, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1465-2016 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.