Exact-Rx Urea Recall: FDA Class III

Why it was recalled

Crystallization; complaints received by the manufacturer of crystals forming in product

Product description

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

Lot numbers, UPCs & expiration codes

Lot #'s: a) 8160, b) 8160 Exp Date: 9/2018

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1465-2016
Classification: Class III
Status: Terminated
Recall initiated: Jun 2, 2016
FDA report date: Aug 31, 2016
Quantity: 6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz)
Recall type: Voluntary: Firm initiated
Recalling firm: Exact-Rx Inc

Original FDA data

Every field from FDA enforcement report D-1465-2016, exactly as published.

Show all FDA fields

City: Melville
State: NY
Status: Terminated
Country: United States
Event ID: 74744
Address: 105 Baylis Rd
Code information: Lot #'s: a) 8160, b) 8160 Exp Date: 9/2018
Postal code: 11747-3833
Report date: Aug 31, 2016
Product type: Drugs
Recall number: D-1465-2016
Classification: Class III
Recalling firm: Exact-Rx Inc
Product quantity: 6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz)
Termination date: Jun 14, 2018
Reason for recall: Crystallization; complaints received by the manufacturer of crystals forming in product
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Nationwide
Recall initiation date: Jun 2, 2016
Initial firm notification: E-Mail
Center classification date: Aug 23, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1465-2016, published Aug 31, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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Exact-Rx Urea Recall

Summary