The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1322-2020·Announced 2020-06-24

Gaviscon Antacid Recalled for Missing Magnesium Safety Warning

GSK is recalling Gaviscon Regular Strength Liquid Antacid bottles because the labels lack a required magnesium safety warning.

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 warning) without reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors.

Plain-English summary

Glaxosmithkline Consumer Healthcare Holdings is recalling 119,364 bottles of Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL). The product is distributed by GSK Consumer Healthcare in Warren, NJ, and is identified by NDC 0135-0094-42.

The recall was initiated because the product labels are missing a required magnesium safety warning. The affected lots are 8M17C1 (Exp 11/30/2020), 9E30C1 (Exp 4/30/2021), and 9F05C1 (Exp 4/30/2021). The product was distributed nationwide in the U.S.A.

Consumers with these specific lot numbers should stop using the product and contact the manufacturer or return it to the place of purchase for a refund or replacement.

The recalled product

Product
GAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE)
Brand
GAVISCON
Manufacturer
Glaxosmithkline Consumer Healthcare Holdings
Category
Drug — OTC Antacid
Hazard
Affected units
119,364

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)

  • Lot #: 8M17C1
  • Exp 11/30/2020
  • 9E30C1
  • Exp 4/30/2021
  • 9F05C1

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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