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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.

Agency Publication Date: April 3, 2013
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Affected Products

Product: Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label is Novartis Consumer Health, Inc., Parsippany, NJ 07054.

Lot #: a) 10086783, 10088745, 10088746, 10090537, 10093867, 10093868, 10098162, 10098541, 10098542, 10102311, 10109145, 10109146, 10120111, 10122759, and 10122760, Exp 3/13 to 9/14; b) 10086785, 10088747, 10088748, 10090538, 10093869, 10093870, 10098160, 10098161, 10098540, 10099841, 10104146, 10109143, 10109144, 10111501, 10115614, 10120112, 10121759, 10122698, 10122757, and 10122758, Exp 3/13 to 10/14.

Product: Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.

Lot #: a) 10109149, 10111499, 10117160, 10119603, and 10121763, Exp 4/13 to 8/13; b) 10109148, 10112258, 10113806, 10115615, 10117161, 10119604, 10119605, 10121782, and 10122762, Exp 3/13 to 9/13.

Product: 4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2086-05), b) 1-fl. oz. bottles (NDC 0067-2086-01), c) 1.25-fl. oz. bottles (NDC 0067-2086-15), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.

Lot #: a) 10108375, 10108376, 10110025, 10110026, 10115487, 10115488, 10120594, 10120595, 10120596, 10120597, 10120753, 10120754, 10120755, 10127564, and 10127567, Exp 4/13 to 11/13, b) 10107916, 10108368, 10108369, 10108370, 10108371, 10108372, 10108373, 10108374, 10110027, 10110028, 10110029, 10110030, 10110031, 10110032, 10110033, 10115803, 10115804, 10115805, 10115806, 10115807, 10115809, 10115810, 10115812, 10115813, 10115814, 10115815, 10120728, 10120737, 10120738, 10120739, 10120740, 10120741, 10120742, 10120743, 10120744, 10120745, 10120746, 10120747, 10120748, 10120749, 10120750, 10120751, 10120752, 10121325, 10127542, 10127543, 10127544, 10127545, 10127546, 10127547, 10127548, 10127549, 10127550, Exp 3/13 to 10/13, c) 10116175, 10117996, 10117997, 10117998, 10117999, 10127535, 10127536, 10127537, 10127538, 10127539, 10127540, and 10127541, Exp 9/13 to 10/13.

Product: 4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2087-05) b) 1-fl. oz. bottles (NDC 0067-2087-01), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.

Lot #: a) 10120598, Exp 7/13; 10127563, Exp 11/13; b) 10107920, 10108362, 10108363, 10108364, 10109881, 10110017, 10110018, 10110019, 10110020, 10120730, 10120731, 10120732, 10120733, 10120734, 10120735, 10120736, 10127556, 10127557, 10127558, and 10127559, Exp 3/13 to 10/13.

Product: 4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.

Lot #: 10107922, 10108365, 10108366, 10108367, 10109874, 10110021, 10110022, 10110023, 10110024, and 10120729, Exp 3/14 to 9/14.

Lot Numbers:
10107922

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 64533
Status: Resolved
Manufacturer: Novartis Consumer Health
Manufactured In: United States
Units Affected: 5 products (240,120/2-oz. tubes and 429,144/4-oz. tubes; 91,872/1-oz. tubes and 94,464/2-oz. tubes; 538,092/.5-fl. oz. bottles, 1,186,740/1-oz. bottles, and 138,528/1.25-fl. oz bottles; 44,604/ .5-fl. oz. bottles and 439,452 /1-fl. oz. bottles; 227,124 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.