When Maalox first disappeared from shelves around here I did a little research and discovered that they had an issue with the FDA over an error in their labeling. Apparently, there’s a small amount of alcohol in the formulation and the amount listed in their ingredients list was incorrect. The amount was so small though that I couldn’t understand why they couldn’t correct the problem with a small stick on label. So I always felt that something else was going on.
Correcting it involves more than a stick on label. They need to requalify the new formulation, assess its equivalence to the old one, take this data and prepare variations to the regulatory dossier in all markets in which the product is sold, then await regulatory approval prior to resuming sales. Stability testing and regulatory inspections by multiple boards of health may also be necessary. The process can take years.