The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1323-2020·Announced 2020-06-24

Gaviscon Antacid Recalled for Missing Magnesium Safety Warning

Gaviscon Regular Strength Liquid Antacid is being recalled because the bottle label lacks the 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, but the source text identifies the issue as a missing safety warning (labeling error) without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling issue.

Plain-English summary

Glaxosmithkline Consumer Healthcare Holdings is recalling 151,344 bottles of Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL). The recall is due to a labeling error where the required magnesium safety warning is not present on the bottle label.

The affected product is distributed nationwide in the U.S. and includes specific lot numbers with expiration dates ranging from July 31, 2020, to May 31, 2021. The product is an over-the-counter oral medication containing aluminum hydroxide and magnesium carbonate.

Consumers should check their bottles for the missing warning and contact the manufacturer for further instructions or a refund if they possess the affected lots.

The recalled product

Product
GAVISCON (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE)
Brand
GAVISCON
Manufacturer
Glaxosmithkline Consumer Healthcare Holdings
Category
Drug — Over-the-Counter Antacid
Hazard
Affected units
151,344

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 (8)

  • Lot #: 8H21C1
  • Exp 7/31/2020
  • 9B25C1
  • Exp 1/31/2021
  • 9D02C1
  • Exp 2/28/2021
  • 9G01C1
  • Exp 5/31/2021

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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