The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0182-2023·Announced 2023-02-01

Advil Liqui Gels Recalled Due to Illegible Labeling Defect

Advil Liqui Gels (200mg ibuprofen capsules) are being recalled nationwide because adhesive on the packaging migrated onto the label, causing it to tear and become illegible when peeled back.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I, establishing a minimum severity score of 4 per the rubric. Although an illegible label on a medication could prevent proper identification or dosing, no illnesses or injuries have been reported.

Plain-English summary

Glaxosmithkline Consumer Healthcare Holdings DBA Haleon, the manufacturer of Advil Liqui Gels, is recalling 88,380 capsules of their 200mg ibuprofen pain reliever due to a labeling defect.

The defect occurs when the adhesive used on the label migrates onto the label surface itself, causing the label to tear when consumers peel it back. This results in illegible labeling that could prevent proper product identification or dosage information.

The recall affects Advil Liqui Gels distributed nationwide in the United States. The affected lot is R94065 with an expiration date of 02/29/2024 (UPC 3 0573 0169 49 3). Pfizer in Madison, NJ is the distributor.

Consumers with affected products should discontinue use and contact the manufacturer or their healthcare provider with questions. This is a Class I recall issued by the U.S. Food and Drug Administration.

The recalled product

Product
Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Distributed by: Pfizer, Madison, NJ 07940, UPC 3 0573 0169 49 3
Manufacturer
Glaxosmithkline Consumer Healthcare Holdings DBA Haleon
Category
Drug — Over-the-Counter Pain Reliever
Hazard
Affected units
88,380

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: R94065
  • Exp 02/29/2024

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Glaxosmithkline Consumer Healthcare Holdings DBA Haleon under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Glaxosmithkline Consumer Healthcare Holdings DBA Haleon

See all →

Same hazard · illegible label

See all →

Similar recalls