Gaviscon Liquid
FDA Recall NDC 0135-0095
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Gaviscon (NDC 0135-0095). A significant event, classified as Class II, was initiated on May 28, 2020 by Haleon Us Holdings Llc. The reported reason for this action was: "Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
May 28, 2020
Jun 24, 2020
119,364 bottles
Recall Profile & Regulatory Data
Event ID
85755
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glaxosmithkline Consumer Healthcare Holdings
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Jan 24, 2022
Product Description
Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-42
Batch or Lot Expiration Information
Lot# : 8M17C1, Exp 11/30/2020; 9E30C1, Exp 4/30/2021; 9F05C1, Exp 4/30/2021
Affected Packages Involved in this Recall
0135-0094-41Product
0135-0094-42Product
0135-0095-41Product
0135-0574-01Product
Class II Terminated
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
May 28, 2020
Jun 24, 2020
151,344 bottles
Recall Profile & Regulatory Data
Event ID
85755
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glaxosmithkline Consumer Healthcare Holdings
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Jan 24, 2022
Product Description
Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-41
Batch or Lot Expiration Information
Lot# : 8H21C1, Exp 7/31/2020; 9B25C1, Exp 1/31/2021; 9D02C1, Exp 2/28/2021; 9G01C1, Exp 5/31/2021
Affected Packages Involved in this Recall
0135-0094-41Product
0135-0094-42Product
0135-0095-41Product
0135-0574-01Product
Class II Terminated
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
May 28, 2020
Jun 24, 2020
1,631,700 bottles & 27,300 Twin-Pack botles
Recall Profile & Regulatory Data
Event ID
85755
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glaxosmithkline Consumer Healthcare Holdings
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Jan 24, 2022
Product Description
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
Batch or Lot Expiration 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
Affected Packages Involved in this Recall
0135-0094-41Product
0135-0094-42Product
0135-0095-41Product
0135-0574-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
