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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Over-the-Counter

Glaxosmithkline Consumer Healthcare Holdings: Gaviscon Liquid Antacids Recalled for Missing Magnesium Safety Warning

Agency Publication Date: June 18, 2020
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Summary

Approximately 2.5 million bottles of Gaviscon Liquid Antacid are being recalled because the labels are missing a mandatory magnesium safety warning. The recall includes various strengths and flavors, such as Regular Strength Cool Mint, Extra Strength Cherry, and Extra Strength Cool Mint, sold in 6-ounce and 12-ounce bottles. This labeling error was initiated voluntarily by Glaxosmithkline Consumer Healthcare after it was discovered that the required precautionary statement for magnesium was not printed on the bottle labels.

Risk

The absence of a magnesium safety warning may lead consumers with certain health conditions, such as kidney disease, to use the product without proper medical guidance. This poses a health risk because individuals with impaired kidney function may not be able to clear magnesium from their bodies effectively, potentially leading to toxic levels in the blood.

What You Should Do

  1. Check your medicine cabinet for Gaviscon Liquid Antacid bottles with the following NDC numbers: 0135-0094-42 (6 oz Cool Mint), 0135-0094-41 (12 oz Cool Mint), 0135-0574-41 (12 oz Cherry), or 0135-0095-41 (12 oz Cool Mint Single and Twin Packs).
  2. Verify the lot numbers and expiration dates on your bottles against the affected list, which includes lots such as 8M17C1 (Exp 11/30/2020), 8H21C1 (Exp 7/31/2020), 0A26C1 (Exp 12/31/2021), and 0A21C1 (Exp 12/31/2021) among many others.
  3. If you have an affected bottle, contact your healthcare provider or pharmacist for guidance, especially if you have kidney disease or are on a magnesium-restricted diet.
  4. Return any unused product to the pharmacy or place of purchase for a full refund.
  5. Contact Glaxosmithkline Consumer Healthcare for further instructions regarding the return or disposal of the product.
  6. For additional questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare consultation and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Gaviscon Regular Strength Liquid Antacid Cool Mint (6 FL OZ / 177 mL)
Model:
NDC 0135-0094-42
Recall #: D-1322-2020
Lot Numbers:
8M17C1 (Exp 11/30/2020)
9E30C1 (Exp 4/30/2021)
9F05C1 (Exp 4/30/2021)
Date Ranges: 11/30/2020, 4/30/2021
Product: Gaviscon Regular Strength Liquid Antacid Cool Mint (12 FL OZ / 355 mL)
Model:
NDC 0135-0094-41
Recall #: D-1323-2020
Lot Numbers:
8H21C1 (Exp 7/31/2020)
9B25C1 (Exp 1/31/2021)
9D02C1 (Exp 2/28/2021)
9G01C1 (Exp 5/31/2021)
Date Ranges: 7/31/2020, 1/31/2021, 2/28/2021, 5/31/2021
Product: Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry (12 FL OZ / 355 mL)
Model:
NDC 0135-0574-41
Recall #: D-1324-2020
Lot Numbers:
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)
Date Ranges: 12/31/2021, 1/31/2022, 10/31/2020, 12/31/2020, 1/31/2021, 2/28/2021, 3/31/2021, 5/31/2021, 6/30/2021, 8/31/2021, 9/30/2021
Product: Gaviscon Liquid Antacid Extra Strength, Cool Mint Single and Twin Pack (12 FL OZ / 355 mL)
Model:
NDC 0135-0095-41
Recall #: D-1325-2020
Lot Numbers:
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 3/31/2021)
9D24C1 (Exp 3/31/2021)
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)
Date Ranges: 7/31/2020 - 12/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85755
Status: Resolved
Manufacturer: Glaxosmithkline Consumer Healthcare Holdings
Sold By: Retail pharmacies; Drugstores; Nationwide retailers
Manufactured In: United States
Units Affected: 4 products (119,364 bottles; 151,344 bottles; 629,796 bottles; 1,631,700 bottles & 27,300 Twin-Pack botles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.