Johnson & Johnson's consumer-product distress worsened on Wednesday as the company recalled 12 million bottles of over-the-counter Mylanta and almost 85,000 bottles of its AlternaGel liquid antacid.
J&J said the actions, which it described as "wholesale and retail level" recalls, were taken because the presence of small amounts of alcohol from flavoring agents was not noted on product packaging.
"It is unlikely that use of these products will cause either alcohol absorption or alcohol sensitivity adverse events," the company said on its Mylanta website.
Although wholesalers and retail outlets are obliged to clear their shelves of the products, the company said consumers may continue to use the medicines, which contained concentrations of less than 1 percent alcohol.
The brands are manufactured as part of a 50/50 joint venture with Merck & Co, formed to develop and make nonprescription drugs primarily derived from Merck's prescription drugs.
J&J said the joint venture's products were made at a J&J plant in Fort Washington, Pennsylvania, that has been shut down to fix hygiene problems and other quality control lapses that in the past year have forced huge recalls of J&J's own iconic consumer brands.
Just a week ago, J&J recalled 9 million bottles of Tylenol because packaging did not adequately inform customers about the presence of trace amounts of alcohol. They were made by a third-party manufacturer.
All told, more than 200 million bottles of J&J products have been recalled in the past year, including painkillers Tylenol and Motrin, allergy treatment Benadryl and Rolaid antacid.
The crisis has harmed J&J's once-pristine image and is beginning to take a significant toll on its financial results. U.S. sales of J&J's consumer products plunged 25 percent in the third quarter as scores of formulations became unavailable and customers opted instead for generic store brands.
Quality-control problems have also hounded J&J's factory in Las Piedras, Puerto Rico, forcing recalls of Benadryl and Tylenol in June.
Wells Fargo analyst Larry Biegelsen on Tuesday cautioned the U.S. Food and Drug Administration could temporarily shut down or seize the Puerto Rico plant, after having recently inspected it and noting unresolved quality-control lapses in an agency report filed November 2.
The negative report, called a Form 483, follows a similar one issued by the FDA after an inspection of the plant in January and February, Biegelsen said.
Biegelsen said the Puerto Rico plant produces most of the over-the-counter drugs sold in the United States by J&J's McNeil consumer healthcare division.