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OTC Acne Med Recalled

Equibal Inc. is recalling 3 lots of Blemfree All Day Lotion that were manufactured without following Current Good Manufacturing Practice regulations, according to the July 17, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in:

  • 1-ounce tubes (NDC 53228-003-01), from lots BF063221 (Exp. 3/4/25) and BF097221 (Exp. 4/7/25); and
  • 4-ounce plastic bottles (NDC 53228-002-01), from lot BF097221 (Exp. 4/7/25).

The affected products were sold online and distributed throughout the United States.

Equibal voluntarily initiated the recall on June 26, 2024. On July 9, 2024, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Blemfree is an over-the-counter product marketed for the management of acne.

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