The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1068-2020·Announced 2020-04-01

GlaxoSmithKline Recalls Advil Allergy and Congestion Relief for Missing Warnings

GlaxoSmithKline is recalling specific lots of Advil Allergy and Congestion Relief 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 and involves a labeling error (missing safety warnings) without reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors.

Plain-English summary

GlaxoSmithKline Consumer Healthcare Holdings is recalling 566 blister packs of Advil Allergy and Congestion Relief 8 pc with $1 IRC. The recall is limited to specific co-packaged batch/lot numbers: 0045DB, 9327VB, 0017DA, and 9353WA, all with an expiration date of 07/31/2021 and original lot number R73995. The product was distributed throughout the United States, including Puerto Rico.

The recall was initiated because certain lots of the product do not include required safety warning information in the Drug Facts Panel. This is a labeling defect where the packaging lacks the necessary Rx legend or safety warnings.

Consumers who have purchased these specific lots should stop using the product and return it to the place of purchase for a refund. The recall number is D-1068-2020.

The recalled product

Product
Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA
Manufacturer
Glaxosmithkline Consumer Healthcare Holdings
Category
Drug — OTC Pain/Allergy
Hazard
Affected units
566

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 (6)

  • Batch/Lot # 0045DB
  • exp. date 07/31/2021
  • original lot # R73995 9327VB
  • original lot # R73995 0017DA
  • original lot # R73995 9353WA
  • original lot # R73995

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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