RecallRadar

FDA Drug recall D-1323-2020

Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0…

On 2020-06-24 the FDA classified a Class II recall of Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0… by Glaxosmithkline Consumer Healthcare Holdings, citing labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1323-2020
ClassificationClass II
Statusterminated
Initiated2020-05-28
Published2020-06-24
Last updated2026-09-13 11:52 UTC
CompanyGlaxosmithkline Consumer Healthcare Holdings
DistributionUS

Product

Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-41

Reason

Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

Identifiers

ndc0135-0094-41
ndc0135-0094-42
ndc0135-0095-41
ndc0135-0574-01
code_infoLot #: 8H21C1, Exp 7/31/2020; 9B25C1, Exp 1/31/2021; 9D02C1, Exp 2/28/2021; 9G01C1, Exp 5/31/2021

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1323-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.