Novartis Recalls Maalox Antacid Tablets Due to Illegible Labeling
Novartis Consumer Health is recalling Maalox Regular Strength Antacid 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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a packaging/labeling defect rather than a product safety hazard.
Plain-English summary
Novartis Consumer Health is voluntarily recalling Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wintergreen flavor, 50-count bottles. The recall is due to a labeling defect where the lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
The affected product is identified by Lot # 10095534 (Exp 07/13) and Lot # 10114311 (Exp 04/14). The recall covers 46,680 bottles that were distributed nationwide in the United States, as well as in Canada and Panama.
Consumers with these products should stop using them and contact Novartis Consumer Health for a refund or replacement. This recall is classified as Class III by the FDA, indicating that the defect is unlikely to cause adverse health consequences.
The recalled product
- Product
- Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wintergreen flavor, 50-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290, UPC 0 58478 44824 4.
- Manufacturer
- Novartis Consumer Health
- Category
- Drug — Antacid
- Hazard
- Affected units
- 46,680
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 (4)
- Lot #: 10095534
- Exp 07/13
- 10114311
- Exp 04/14
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