The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1324-2020·Announced 2020-06-24

Gaviscon Extra Strength Liquid Antacid Recalled for Missing Magnesium Warning

GSK is recalling Gaviscon Extra Strength Liquid Antacid because the bottle label is missing 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 the hazard is a minor labeling error (missing safety warning) rather than a direct contamination or structural defect.

Plain-English summary

Glaxosmithkline Consumer Healthcare Holdings is recalling Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), NDC 0135-0574-41. The recall involves 629,796 bottles distributed nationwide in the United States.

The recall was initiated because the product label lacks a required magnesium safety warning. The affected lots include 0A26C1, 0B10C1, 8L19C1, 8L27C1, 9A28C1, 9B18C1, 9C19C1, 9D09C1, 9F20C1, 9G24C1, 9J09C1, 9K29C1, and 9L05C1, with expiration dates ranging from October 31, 2020, to September 30, 2021.

Consumers should check their bottles for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, consumers should stop using it and contact the manufacturer for instructions on how to return the product or obtain a refund.

The recalled product

Product
Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0574-41
Manufacturer
Glaxosmithkline Consumer Healthcare Holdings
Category
Drug — Antacid
Hazard
Affected units
629,796

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 #: 0A26C1
  • Exp 12/31/2021
  • 0B10C1
  • Exp 1/31/2022
  • 8L19C1
  • Exp 10/31/2020
  • 8L27C1
  • 9A28C1
  • Exp 12/31/2020
  • 9B18C1
  • Exp 1/31/2021
  • 9C19C1
  • Exp 2/28/2021
  • 9D09C1
  • Exp 3/31/2021
  • 9F20C1
  • Exp 5/31/2021
  • 9G24C1
  • Exp 6/30/2021
  • 9J09C1

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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