The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1065-2020·Announced 2020-04-01

Advil Allergy and Congestion Relief Recalled for Missing Safety Warnings

Glaxosmithkline is recalling specific lots of Advil Allergy and Congestion Relief tablets because they 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 due to a labeling error (missing safety warnings). Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity category.

Plain-English summary

Glaxosmithkline Consumer Healthcare Holdings is recalling 471,024 blisters of Advil Allergy and Congestion Relief tablets. The affected product contains ibuprofen 200 mg, chlorpheniramine maleate 4 mg, and phenylephrine hydrochloride 10 mg. The recall is due to a labeling defect where certain lots do not include required safety warning information in the Drug Facts Panel.

The affected lots are R73995 (exp. 07/31/2021), R53915 (exp. 05/31/2020), 9324HA (exp. 07/31/2021), and 9327HA (exp. 07/31/2021). The product was distributed throughout the United States, including Puerto Rico. The FDA has classified this as a Class II recall.

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

The recalled product

Product
ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE)
Brand
ADVIL ALLERGY AND CONGESTION RELIEF
Manufacturer
Glaxosmithkline Consumer Healthcare Holdings
Category
Drug — OTC Combination
Hazard
Affected units
471,024

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 (5)

  • Batch/Lot Numbers: R73995
  • exp. date 07/31/2021 R53915
  • exp. date 05/31/2020 9324HA
  • exp. date 07/31/2021 9327HA
  • exp. date 07/31/2021

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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