CLASS III Drug recall · Reported 28 Aug 2013 · FDA Enforcement Report
Maalox Extra Strength Antacid with Anti-Gas recalled
Novartis Consumer Health is recalling Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable, distributed nationwide in the US. The recall was initiated on 6 Aug 2013 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-908-2013
- FDA event ID
- 65840
- Recalling firm
- Novartis Consumer Health, Lincoln, NE
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Aug 2013
- FDA classified
- 20 Aug 2013
- Reported
- 28 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
Timeline
| 6 Aug 2013 | Recall initiated by company | |
| 20 Aug 2013 | Classified by FDA | +14 days |
| 28 Aug 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 600 mg/60 mg, Wild Berry flavor, 35-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243496, UPC 0 58478 44840 4.
Where it was distributed
Nationwide, Canada, and Panama.
Questions about this recall
Why was it recalled?
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Which lots are affected?
Lot #: 10093133, Exp 06/13; 10099452, Exp 09/13; 10104667, Exp 12/13; 10110926, Exp 02/14; 10114316, Exp 04/14; 10120623, Exp 07/14; 10123098, Exp 09/14
Where was it sold?
Nationwide, Canada, and Panama.
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.
Other products in this recall event
8 other products · FDA event 65840This product is part of a recall event; the main page for the event is Maalox Nighttime Antacid with Acid Reflux Barrier recalled.
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