The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1069-2020·Announced 2020-04-01

Advil Liqui-Gel Mini Recalled for Missing Safety Warnings

Glaxosmithkline is recalling specific lots of Advil Liqui-Gel Mini because the Drug Facts Panel lacks required safety warning information.

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 due to a labeling error (missing safety warnings). Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are typically scored as Moderate (2).

Plain-English summary

Glaxosmithkline Consumer Healthcare Holdings is recalling 4,104 bottles of Advil Liqui-Gel Mini 160+20+20 CT (e-commerce). The recall involves specific lots identified by Batch/Lot # 0198FR and # 3188FRB, both with an expiration date of 10/31/2020. The product was distributed throughout the United States, including Puerto Rico.

The recall was initiated because certain lots do not include required safety warning information in the Drug Facts Panel. This labeling deficiency means the packaging lacks specific safety warnings or the Rx legend required by regulations.

Consumers who have purchased these specific lots should stop using the product and contact the manufacturer or their point of purchase for a refund or replacement. The recall is classified as FDA Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product
Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packaged Batch/Lot # 0198FR & 3188FRB
Manufacturer
Glaxosmithkline Consumer Healthcare Holdings
Category
Drug — Over-the-Counter Medication
Hazard
Affected units
4,104

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 (4)

  • Batch/Lot # Lot # 0198FR
  • original lot # R53074
  • exp. date 10/31/2020 Lot # 3188FRB
  • exp. date 10/31/2020

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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