The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1066-2020·Announced 2020-04-01

Advil Liqui-Gel Minis Recalled for Missing Safety Warnings

Glaxosmithkline is recalling 446,628 bottles of Advil Liqui-Gel Minis because certain lots lack required safety warning information in the Drug Facts Panel.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (missing safety warnings) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Glaxosmithkline Consumer Healthcare Holdings is recalling 446,628 bottles of Advil Liqui-Gel Minis (Ibuprofen 200 mg liquid filled capsules, 160 count). The recall affects specific lots identified by batch numbers R53074, R53075, R53076, R53077, R53081, R53901, R53902, and R62780, with expiration dates ranging from October 2020 to June 2021.

The recall was initiated because certain lots do not include required safety warning information in the Drug Facts Panel. This labeling deficiency means consumers may not be aware of necessary safety precautions associated with the medication.

The product was distributed throughout the United States, including Puerto Rico. Consumers should check their bottles for the affected lot numbers and expiration dates. If the product matches the recalled lots, consumers should stop using it and contact the manufacturer or a healthcare provider for guidance.

The recalled product

Product
ADVIL (IBUPROFEN)
Brand
ADVIL
Manufacturer
Glaxosmithkline Consumer Healthcare Holdings
Category
Drug — OTC Pain Reliever
Hazard
Affected units
446,628

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 (15)

  • Batch/Lot Numbers: R53074
  • exp. date 10/31/2020
  • item # F00573176989
  • 160 ct. R53075
  • 160 ct. R53076
  • exp. date 11/30/2020
  • 160 ct. R53077
  • 160 ct. R53081
  • 160 ct. R53901
  • exp. date 02/28/2021
  • 160 ct. R53902
  • exp. date 03/31/2021
  • 160 ct. R62780
  • exp. date 06/30/2021
  • 160 ct.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 5 recalled by Glaxosmithkline Consumer Healthcare Holdings 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 5 products in this recall →

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