The Recall Desk
LowFDA (Drugs)·D-908-2013·Announced 2013-08-28

Novartis Recalls Maalox Extra Strength Antacid Due to Illegible Labeling

Novartis is recalling Maalox Extra Strength Antacid chewable tablets because the lot number or 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 indicates the product is not likely to cause adverse health consequences. The issue is a cosmetic or documentation defect (illegible labeling) rather than a safety hazard.

Plain-English summary

Novartis Consumer Health is recalling Maalox Extra Strength Antacid with Anti-Gas chewable tablets, 600 mg/60 mg, Wild Berry flavor, 35-count bottles. The recall involves 129,048 bottles distributed nationwide in the United States, as well as in Canada and Panama.

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.

Consumers who have this product should check the packaging for illegible lot or expiration dates. The affected lots include 10093133, 10099452, 10104667, 10110926, 10114316, 10120623, and 10123098. Consumers should contact Novartis Consumer Health for further instructions or a refund.

The recalled product

Product
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 02243
Affected units
129,048

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 (14)

  • 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

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 →