Novartis Recalls Maalox Extra Strength Antacid Tablets Due to Illegible Labeling
Novartis is recalling Maalox Extra Strength Antacid with Anti-Gas chewable tablets because the lot number and expiration date may be illegible on the packaging.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is limited to packaging and labeling issues.
Plain-English summary
Novartis Consumer Health is recalling 117,816 bottles of Maalox Extra Strength Antacid with Anti-Gas chewable tablets. The product is a 65-count bottle containing calcium carbonate and simethicone in Assorted Fruit flavor.
The recall was initiated because the lot number and/or expiration date may be illegible on the outer plastic bottle packaging. This labeling issue prevents consumers from verifying the specific lot and expiration date of the product.
The affected product was distributed nationwide in the United States, as well as in Canada and Panama. Consumers should check their bottles for the specific lot numbers and expiration dates listed in the recall notice and stop using the product if it matches the recalled lots.
The recalled product
- Product
- Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN
- Manufacturer
- Novartis Consumer Health
- Category
- Drug — Antacid
- Hazard
- Affected units
- 117,816
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot #: 10097345
- Exp 08/13
- 10104668
- Exp 01/14
- 10114317
- Exp 03/14
- 10120624
- Exp 07/14
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Novartis Consumer Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Novartis Consumer Health
See all →- ModerateNovartis Recalls Benefiber Fiber Supplement Stick Packs Due to Consumer Complaints
FDA (Food) · 2014-03-05
- ModerateNovartis Recalls Theraflu Severe Cold & Cough Powder Packets for Foreign Substances
FDA (Drugs) · 2014-01-29
- HighNovartis Recalls Theraflu Powder Packets Due to Foreign Substance Presence
FDA (Drugs) · 2014-01-29
- ModerateNovartis Recalls NeoCitran Extra Strength Powder Packets Due to Foreign Substances
FDA (Drugs) · 2014-01-29
- ModerateNovartis Recalls Theraflu Exte Powder Packets Due to Foreign Substances
FDA (Drugs) · 2014-01-29
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02