The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1325-2020·Announced 2020-06-24

Gaviscon Liquid Antacid Recalled for Missing Magnesium Safety Warning

Gaviscon Liquid Antacid Extra Strength is being recalled because the bottle label lacks a required magnesium safety warning. The recall covers single and twin-pack bottles distributed nationwide.

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 labeling error (missing warning) without reporting any illnesses or injuries. This aligns with the rubric for moderate severity involving minor labeling errors or low-risk issues.

Plain-English summary

Glaxosmithkline Consumer Healthcare Holdings is recalling Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single and twin-pack bottles. The recall was initiated because the product label is missing the required magnesium safety warning.

The affected product is identified by NDC 0135-0095-41 and includes specific lot numbers with expiration dates ranging from July 31, 2020, to November 30, 2021. The recall covers 1,631,700 single bottles and 27,300 twin-pack bottles distributed nationwide in the U.S.A.

Consumers with this product should check their bottles for the missing warning and the specific lot numbers listed in the recall notice. If the product matches the description, consumers should stop using it and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

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

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 (20)

  • Lot #: 0A21C1
  • Exp 12/31/2021
  • 0A31C1
  • 0B05C1
  • 8J04C1
  • Exp 7/31/2020
  • 8L05C1
  • Exp 9/30/200
  • 8L13C1
  • Exp 10/31/2020
  • 9A14C1
  • Exp 12/31/2020
  • 9A21C1
  • 9B04C1
  • 9B11C1
  • Exp 1/31/2021
  • 9C04C1
  • 9C12C1
  • Exp 2/28/2021
  • 9C25C1

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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