The reason that experts cite seems a little unusual, but it's better to be aware of before you try to apply.
23,000 Bottles of a Skincare Product Have Been Recalled Nationwide
Published on Jan. 06, 2025
There’s no question “clean beauty” is in, and hopefully it’s here to stay. But some needs for the condition or appearance of your complexion simply might call for prescription, in which case you’re trusting in your prescriber and the maker of the product to be sure the ingredients pose as minimal risk to your health as possible.
A recent issue with an acne prescription is a reminder that sometimes, changes to the product can occur between manufacturing and reaching consumers’ cabinets. The U.S. Food and Drug Administration (FDA) has announced a recall of 23,304 bottles of a popular prescription skincare product: Dapsone Gel 7.5%. This topical antibiotic, sometimes branded under brand names such as Nurx or Aczone, is a once-daily acne treatment that for some patients may result in improvements to the skin in 12 weeks of use.
Triggering the recall, samples of the product were found to have undergone crystallization. Though the FDA did not elaborate on how this could cause harm to consumers in the case of this particular incident, past recalls have suggested that when the active ingredient in a topical product crystalizes, this could lead to incorrect dosing.
On January 2, 2025, the FDA designated the recall a Class II risk level, suggesting that use of the product could cause temporary or reversible harm, but is unlikely to cause serious illness or death. However, the Cleveland Clinic notes that accidental overuse of dapsone gel can become a medical emergency. “If you think you have taken too much of this medicine, contact a poison control center or emergency room at once,” their experts write.
The affected Dapsone Gel 7.5%, distributed by Viona Pharmaceuticals Inc. of Cranford, NJ, and manufactured by Zydus Lifesciences Ltd. of Ahemedabad, India, was sold in 60-gram airless pump packs, shaped in cylindrical tubes. Both the tubes and their box packaging are said to be white with pink accents and black lettering. The implicated products bear a National Drug Code (NDC) of 72578-094-02. You can also identify the products using their lot codes and expiration dates:
- Lot T400513, Exp Date 02/2026
- Lot T400807, Exp Date 03/2026
- Lot T401152, Exp Date 06/2026
- Lot T401303, Exp Date 07/2026
- Lot T401304, Exp Date 07/2026
- Lot T401399, Exp Date 07/2026
- Lot T401696 Exp Date 08/2026
As the Cleveland Clinic further explains, dapsone gel is typically applied directly to acne-prone skin and “works by killing or preventing the growth of bacteria on the skin,” they note. Though everyone has some bacteria on their skin, having too much, or the wrong types, can clog your pores and trigger inflammation, leading to breakouts.
Dapsone gel is approved for pediatric use in patients aged nine and up. It is not clear from the recall notice whether children would be at higher risk of adverse effects. (All usage for any age demographic should be under the supervision of a credentialed healthcare professional.)
If you have been prescribed Dapsone Gel 7.5%, and believe you may have the affected lots in your possession, speak with your doctor about requesting a replacement.
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