Maalox Extra Strength (Novartis) – illegible labeling (2013)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry flavor, packaged in a) 35-count (UPC 0 58478 44829 9) and b) 65-count (UPC 0 58478 44842 8) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238291.
Brand
Novartis Consumer Health
Lot Codes / Batch Numbers
Lot #: a) 10095535, Exp 07/13, 10101288, Exp 10/13, 10104665, Exp 01/14, 10111114, Exp 02/14, 10114314, Exp 04/14, 10120621, Exp 07/14, b) 10095536, Exp 07/13, 10101289, Exp 10/13, 10104666, Exp 01/14, 10111116, Exp 02/14, 10114315, Exp 04/14, 10120622, Exp 07/14
Products Sold
Lot #: a) 10095535, Exp 07/13; 10101288, Exp 10/13; 10104665, Exp 01/14; 10111114, Exp 02/14; 10114314, Exp 04/14; 10120621, Exp 07/14; b) 10095536, Exp 07/13; 10101289, Exp 10/13; 10104666, Exp 01/14; 10111116, Exp 02/14; 10114315, Exp 04/14; 10120622, Exp 07/14
Novartis Consumer Health is recalling Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry flavor, packa due to 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.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026