CLASS III Drug recall · Reported 5 Jul 2017 · FDA Enforcement Report
Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength recalled
Sanofi-Aventis U.S is recalling Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable, distributed nationwide in the US. The recall was initiated on 12 Jun 2017 and the FDA has classified it as Class III.
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-0926-2017
- FDA event ID
- 77478
- Recalling firm
- Sanofi-Aventis U.S, Bridgewater, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Jun 2017
- FDA classified
- 29 Jun 2017
- Reported
- 5 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 12 Jun 2017 | Recall initiated by company | |
| 29 Jun 2017 | Classified by FDA | +17 days |
| 5 Jul 2017 | 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
Superpotent Drug: high out-of-specification result for magnesium.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P., Moon Twp, PA 15108, UPC 3 0088-1175-47 8.
Where it was distributed
Nationwide in the USA, Puerto Rico, and the United Kingdom.
Questions about this recall
Why was it recalled?
Superpotent Drug: high out-of-specification result for magnesium.
Which lots are affected?
Lot #: 5J69A, Exp 02/19; 6GF2A, 6GF3A, Exp 08/19
Where was it sold?
Nationwide in the USA, Puerto Rico, and the United Kingdom.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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