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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug

Novartis Consumer Health: 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.; 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.

Agency Publication Date: August 20, 2013
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Affected Products

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 02243496, UPC 0 58478 44872 5.

Lot #: 10097345, Exp 08/13; 10104668, Exp 01/14; 10114317, Exp 03/14; 10120624, Exp 07/14

Lot Numbers:
10097345
Product: Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry flavor, packaged in a) 50-count (UPC 0 58478 44825 1), b) 100-count (UPC 0 58478 44826 8) and c) 145-count (UPC 0 58478 44836 7) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290.

Lot #: a) 10095538, Exp 07/13; 10099449, Exp 09/13; 10104663, Exp 01/14; 10111110, Exp 02/14; 10114312, Exp 04/14; 10120619, Exp 07/14; b) 10095537, Exp 07/13; 10099451, Exp 09/13; 10104664, Exp 01/14; 10111112, Exp 02/14; 10114313, Exp 04/14; 10120620, Exp 07/14; c) 10095528, Exp 07/13; 10106998, Exp 01/14; 10120618, Exp 07/14

Product: Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Wild Berry flavor, 65-count tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-62791-65, UPC 3 0067-0376-65 9.

Lot #: 10093113, Exp 06/13; 10097332, Exp 08/13; 10101258, Exp 10/13; 10104632, Exp 12/13; 10108852, Exp 01/14; 10104633, 10110688, Exp 02/14; 10111944, Exp 03/14; 10114325, Exp 05/14; 10120609, 10120610, Exp 07/14; 10123084, Exp 09/14

Lot Numbers:
10093113
Product: Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, packaged in a) 35-count (NDC 0067-6279-35) (UPC 3 0067-0343-35 4); b) 65-count (NDC 0067-6279-65) (UPC 3 0067-0343-65 1); and c) 90-count (NDC 0067-6279-90) (UPC 3 0067-0343-90 3) tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.

Lot #: a) 10090971, Exp 08/13; 10101253, Exp 09/13; 10102751, Exp 11/13; 10104624, Exp 01/14; 10108954, 10108955, Exp 02/14; 10111942, 10111943, Exp 03/14, 10117575, Exp 04/14; b) 10095525, Exp 07/13; 10097329, Exp 08/13; 10099437, 10101254, Exp 09/13; 10101255, 10102752, Exp 10/13; 10104625, 10104626, Exp 11/13; 10104627, 10109871, 10110711, 10109182, Exp 01/14; 10109872, 10110003, Exp 02/14; 10111941, Exp 03/14; 10115413, 10116855, Exp 04/14; 10118565, 10118566, Exp 06/14; 10120611, 10120612, Exp 07/14; 10123086, Exp 08/14; c) 10093109, 10093111, 10093112, Exp 06/13; 10095529, 10095540, Exp 07/13; 10097330, 10097331, Exp 08/13; 10099438, 10099439, 10099440, Exp 09/13; 10101256, 10101257, Exp 10/13; 10102753, 10102754, 10104628, Exp 11/13; 10104629, Exp 12/13; 10104630, 10104631, 10108289, 10108290, Exp 01/14; 10107564, 10109868, 10110004, 10110005, Exp 02/14; 10111938, 10111939, 10113621, 10113622, 10114320, 10114321, Exp 03/14; 10114322, 10114323, 10116852, Exp 04/14; 10116853, Exp 05/14; 10118563, 10118564, Exp 06/14; 10120613, 10120614, Exp 07/14; 10123087, 10123088, 10123089, Exp 08/14; 10126000, 10126001, 10126002, Exp 09/14; 10128831, 10128833, Exp 10/14

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.

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

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.

Lot #: 10095534, Exp 07/13; 10114311, Exp 04/14

Lot Numbers:
10095534
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 02243496, UPC 0 58478 44840 4.

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

Lot Numbers:
10093133
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 80000899, UPC 0 58478 10091 3.

Lot #: 10107000, Exp 07/13; 10114319, Exp 01/14

Lot Numbers:
10107000
Product: Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Cherry flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80000899, UPC 0 58478 10090 6.

Lot #: 10114318, Exp 01/14

Lot Numbers:
10114318

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 65840
Status: Resolved
Manufacturer: Novartis Consumer Health
Manufactured In: United States
Units Affected: 9 products (117,816 bottles; 112,728 bottles; 410,220 bottles; 3,451,224 bottles; 149,616 bottles; 46,680 bottles; 129,048 bottles; 23,856 bottles; 11,760 bottles)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.