Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85755

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 28, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Glaxosmithkline Consumer Healthcare Holdings

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 4

Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-42

D-1322-2020
Recall number
D-1322-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Quantity
119,364 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

U.S.A. Nationwide

drug · product 2 of 4

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

D-1323-2020
Recall number
D-1323-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Quantity
151,344 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

U.S.A. Nationwide

drug · product 3 of 4

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

D-1324-2020
Recall number
D-1324-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Quantity
629,796 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 0A26C1, Exp 12/31/2021; 0B10C1, Exp 1/31/2022; 8L19C1, Exp 10/31/2020; 8L27C1, Exp 10/31/2020; 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, Exp 8/31/2021; 9K29C1, Exp 9/30/2021; 9L05C1, Exp 9/30/2021

Distribution pattern

U.S.A. Nationwide

drug · product 4 of 4

Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single pack and twin pack, Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0095-41

D-1325-2020
Recall number
D-1325-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Quantity
1,631,700 bottles & 27,300 Twin-Pack botles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 0A21C1, Exp 12/31/2021; 0A31C1, Exp 12/31/2021; 0B05C1, Exp 12/31/2021; 8J04C1, Exp 7/31/2020; 8L05C1, Exp 9/30/200; 8L13C1 , Exp 10/31/2020; 9A14C1, Exp 12/31/2020; 9A21C1, Exp 12/31/2020; 9B04C1, Exp 12/31/2020; 9B11C1, Exp 1/31/2021; 9C04C1, Exp 1/31/2021; 9C12C1, Exp 2/28/2021; 9C25C1, Exp 2/28/2021; 9D17C1, Exp 3/312021; 9D24C1, Exp 3/312021; 9E01C1, Exp 3/31/2021; 9E10C1, Exp 3/31/2021; 9E21C1, Exp 4/30/2021; 9F11C1, Exp 5/31/2021; 9G15C1, Exp 6/30/2021; 9G30C1, Exp 6/30/2021; 9H06C1, Exp 6/30/2021; 9H12C1, Exp 7/31/2021, 9H2OC1, Exp 7/31/2021; 9H26C1, Exp 7/31/2021; 9J23C1, Exp 8/31/2021; 9J3OC1, Exp 8/31/2021; 9K08C1, Exp 8/31/2021; 9L11C1, Exp 10/31/2021; 9L18C1, Exp 10/31/2021; 9M02C1, Exp 10/31/2021; 9M09C1, Exp 11/30/2021; 9M17C1, Exp 11/30/2021; 19N1587221, Exp 7/31/2020; 19N1743754, Exp 12/31/2020; 19N1948440, Exp 6/30/2021; 19N1958219, Exp 6/30/2021; 20N2019997, Exp 7/31/2021; 20N2026258, Exp 8/31/2021; 20N2057778, Exp 8/31/2021

Distribution pattern

U.S.A. Nationwide

Field note

Send feedback

We'll only use this to respond to your feedback.