Novartis Recalls Maalox Nighttime Antacid Due to Illegible Packaging Labels
Novartis Consumer Health is recalling Maalox Nighttime Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 legibility issues.
Plain-English summary
Novartis Consumer Health is recalling 23,856 bottles of Maalox Nighttime Antacid with Acid Reflux Barrier chewable tablets. The product is a 65-count bottle containing calcium carbonate and alginic acid in Mint flavor. The recall was initiated because the lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
The affected products are identified by Lot # 10107000 (Exp 07/13) and Lot # 10114319 (Exp 01/14). The product was distributed nationwide in the United States, as well as in Canada and Panama. The manufacturer is Novartis Consumer Health Canada Inc., located in Mississauga, ON.
Consumers with this product should check the packaging for the specific lot numbers and expiration dates listed above. If the lot number or expiration date is illegible, consumers should stop using the product and contact Novartis Consumer Health for further instructions.
The recalled product
- Product
- Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Mint flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN…
- Manufacturer
- Novartis Consumer Health
- Category
- Drug — Antacid
- Hazard
- Affected units
- 23,856
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 #: 10107000
- Exp 07/13
- 10114319
- Exp 01/14
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 →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- LowNovartis Recalls Benefibre Orange Creme Chewables Due to Illegible Labeling
FDA (Food) · 2013-09-25
- LowNovartis Recalls Benefiber Wild Berry Chewables Due to Illegible Labeling
FDA (Food) · 2013-09-25
- LowNovartis Recalls Cataflam Tablets Due to Illegible Ink Identification
FDA (Drugs) · 2014-08-13
- LowNovartis Recalls Benefiber Fiber Supplement Due to Illegible Packaging Labels
FDA (Food) · 2013-09-25
- LowNovartis Recalls Lamisil AT Cream Due to Illegible Labeling
FDA (Drugs) · 2013-06-12
- LowNovartis Recalls Myoflex Cream Due to Illegible Lot and Expiration Dates
FDA (Drugs) · 2013-03-27