Safety Alerts & Recalls

What does this mean?

Although this is not a recall warning, the safety of unapproved drugs is unknown. Topical ibuprofen is often promoted as a "safer" alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen. However, these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the FDA evaluated what other side effects might be associated with these products.

This warning only applies to topical ibuprofen creams, ointments, or gels that are applied to the skin. If you are using a topical ibuprofen product, please stop using this product and follow up with your doctor to discuss the other available treatments for pain and inflammation.

FDA Sends Warning Letters to Marketers of Topical Ibuprofen Products

The FDA has issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen. The topical products, which contain ibuprofen in combination with a variety of other ingredients, have not been approved by the FDA. These topical ibuprofen products that are applied to the skin and marketed as pain relievers have not been evaluated for safety or effectiveness.

The names of the products and manufacturers that received warning letters are: Emuprofen (Progressive Emu, Inc.)

BioEntopic 15% Ibuprofen Creme (BioCentric Laboratories, Inc.)

Ibunex Topical Ibuprofen (Core Products International, Inc.)

LoPain AF 15% Ibuprofen Creme (Geromatrix Health Products)


Profen HP (Ridge Medical Products)

IbuPRO-10 Plus (Meditrend, Inc., Progena Professional Formulations)

IBU-RELIEF 12 (Wonder Laboratories)

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-08-21
Last Updated: 2009-12-05

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