The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1067-2020·Announced 2020-04-01

Infants Advil Recalled for Missing Safety Warnings in Drug Facts Panel

Glaxosmithkline is recalling specific lots of Infants Advil (Ibuprofen) 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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error (missing warnings) rather than a physical defect or contamination, fitting the 'Minor labeling errors' criterion for a Moderate severity score.

Plain-English summary

Glaxosmithkline Consumer Healthcare Holdings is recalling 151,056 bottles of Infants Advil (Ibuprofen) 50 mg per 1.25 mL Oral Suspension. The recall involves specific 0.75 oz. and 1 oz. bottles of the White Grape flavored product. The affected lots were 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 product lacks the necessary warnings or Rx legend as required by regulations.

Consumers should check their bottles for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
INFANTS ADVIL (IBUPROFEN)
Brand
INFANTS ADVIL
Manufacturer
Glaxosmithkline Consumer Healthcare Holdings
Category
Drug — OTC Pediatric Pain Reliever
Hazard
Affected units
151,056

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 (14)

  • Batch/Lot # R73761
  • exp. date 01/31/2021
  • Item # F00573019175
  • 0.75 oz. R74936
  • exp. date 02/28/2021
  • 0.75 oz. R56290
  • exp. date 03/31/2020
  • Item # F00573019150
  • 1 oz. R60959
  • 1 oz. R78826
  • exp. date 11/30/2021
  • 1 oz. 9335UA
  • item # F00573019175A - Co-package 9336UA
  • item # F00573019175A - Co-package

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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