CLASS II Drug recall · Reported 24 Jun 2020 · FDA Enforcement Report
Gaviscon Regular Strength Liquid Antacid Cool Mint recalled
Glaxosmithkline Consumer Healthcare Holdings is recalling Gaviscon Regular Strength Liquid Antacid Cool Mint, distributed nationwide in the US. The recall was initiated on 28 May 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1322-2020
- FDA event ID
- 85755
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings, Warren, NJ
- Brand
- Gaviscon
- Manufacturer
- Haleon US Holdings LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 May 2020
- FDA classified
- 18 Jun 2020
- Reported
- 24 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 28 May 2020 | Recall initiated by company | |
| 18 Jun 2020 | Classified by FDA | +21 days |
| 24 Jun 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Product as listed by the FDA
Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-42
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Which lots are affected?
Lot #: 8M17C1, Exp 11/30/2020; 9E30C1, Exp 4/30/2021; 9F05C1, Exp 4/30/2021
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 85755This product is part of a recall event; the main page for the event is Gaviscon Regular Strength Liquid Antacid Cool Mint recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Gaviscon Regular Strength Liquid Antacid Cool Mint recalledGaviscon | Glaxosmithkline Consumer Healthcare Holdings | Other | Nationwide | |
| CLASS II | Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry recalled | Glaxosmithkline Consumer Healthcare Holdings | Other | Nationwide | |
| CLASS II | Gaviscon Liquid Antacid Extra Strength recalledGaviscon | Glaxosmithkline Consumer Healthcare Holdings | Other | Nationwide |
More recalls from Glaxosmithkline Consumer Healthcare Holdings
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalled | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalled | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalledTums | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalledTums | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalledTums | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
Other Aluminum Hydroxide recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gaviscon Liquid Antacid Extra Strength recalledGaviscon | Glaxosmithkline Consumer Healthcare Holdings | Other | Nationwide |
| Drug | CLASS II | Gaviscon Regular Strength Liquid Antacid Cool Mint recalledGaviscon | Glaxosmithkline Consumer Healthcare Holdings | Other | Nationwide |