Class I Recall for Advil

Illegible product labels have prompted a Class I recall of several lots of Advil (ibuprofen) tablets and capsules. According to the February 1, 2023, US Food and Drug Administration (FDA) Enforcement Report, “adhesive migrated onto a portion of the label, causing it to tear when peeled back.” The FDA’s most serious classification, Class I designations warn that use of the affected product could cause serious adverse health consequences or death.

The recall affects the following Advil products, which were distributed throughout the United States:

• Advil (ibuprofen) tablets, 200 mg, in 360-count bottles (UPC 3 0573 0154 60 4), from lots EJ2218, EJ2219, and EJ2220 (Exp. 9/23);
• Advil (ibuprofen) tablets, 200 mg, in 200-count bottles (UPC 3 0573 0154 21 5), from lot 953D (Exp. 5/25);
• Advil Liqui Gels, solubilized ibuprofen capsules, 200 mg, 200 liquid-filled capsules (UPC 3 0573 0169 49 3), from lot R94065 (Exp. 2/29/24); and
• Advil Liqui Gels (minis), solubilized ibuprofen capsules, 200 mg, 200 liquid-filled capsules (UPC 3 0573 1769 13 5), from lots R93517, R94072, and R94073 (Exp. 2/29/24), and T00655 (Exp. 3/31/25).

GlaxoSmithKline Consumer Healthcare Holdings, doing business as Haleon, voluntarily initiated the recall December 6, 2022. The FDA designated the recall Class I on January 25, 2023. 

Advil is an over-the-counter pain reliever and fever reducer.