Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Urea (50% Urea in a Cream Base) Recalled by Exact-Rx Inc Due to Crystallization; complaints received by the manufacturer of crystals...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Exact-Rx Inc directly.
Affected Products
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
Quantity: 6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz)
Why Was This Recalled?
Crystallization; complaints received by the manufacturer of crystals forming in product
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Exact-Rx Inc
Exact-Rx Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report