(NEW YORK) — In a new recall following a separate one which dogged them for the better part of this year, Abbott, which has been the largest infant formula manufacturer in the U.S., is now voluntarily recalling bottles of their largest, most popular kind of formula, Similac, from their manufacturing facility in Columbus, Ohio.
This recall is not for the bacterial contamination concerns which prompted the massive voluntary recall at their plant in Sturgis, Michigan, earlier this year.
The new recall in Ohio is because the bottle caps on some of their 2-ounce ready-to-feed liquid products made at the Columbus plant are faulty, and may not have sealed completely, the company said in a recall notice.
If formula bottles aren’t sealed properly, it could result in spoilage, Abbott said. Babies could develop painful gastrointestinal symptoms like diarrhea and vomiting if they consume spoiled products, according to the company.
Abbott underscores that only a “small percentage, less than 1%” of bottles in these recalled lots have faulty caps, according to a statement. The company says they “internally identified the issue and are addressing it.”
While this is yet another setback for Abbott, industry experts say it is an important part of the oversight system: for companies to rigorously self-monitor their safety and quality control processes and catch problems before they get worse.
Abbott declined to provide an exact number of bottles being recalled now, but said in the statement it “equates to less than one day’s worth of the total number of ounces of infant formula fed in the U.S. and is not expected to impact the overall U.S. infant formula supply.”
Even so — that still means this recall could temporarily keep millions of bottles off the shelves, in a market still recouping from the months’ long formula crisis this spring.
Between 2 and 3 million babies in the U.S. rely to some degree on formula every day, experts have told ABC. On average, infants drink between four and six 8-ounce bottles’ worth of formula a day. That includes unfinished or spilt bottles, and naturally fluctuating appetites from day to day. Multiplied out — that means American babies need somewhere between 10 and 12 million bottles per day.
The recall from the Columbus facility impacts smaller, 2-ounce bottles, of which more are required for a day’s worth of feeding.
Abbott is still continuing production of these popular Similac products on a different production line at the facility, the company said.
Abbott’s formula industry dominance made their abrupt absence this spring a strain on the U.S. market. When their Sturgis production was shut down amid Cronobacter contamination concerns, it sent the U.S. formula market into a tailspin.
Amid the dire shortage, Abbott ramped up production at their Columbus facility in an attempt to mitigate some of the shortage.
Abbott converted manufacturing lines at their Columbus plant to increase production of Similac and Alimentum liquid ready-to-feed formula — something the company repeatedly touted to the public and in congressional testimony.
Abbott says the products included in the Columbus plant recall were distributed “primarily to hospitals and to some doctors’ offices, distributors and retailers in the U.S., including Puerto Rico; one lot of products was sent to Barbados, Bermuda, Colombia, the Dominican Republic, Haiti, Jamaica, St. Croix and St. Thomas; and two lots were sent to Canada, Curacao, Panama, and Trinidad and Tobago.”
The company advises parents to check whether formula they have was recalled at similacrecall.com, and if it is, not to use it.
Abbott says their recall includes the brands Similac® Pro-Total ComfortTM, Similac® 360 Total Care®, Similac 360 Total Care Sensitive, Similac® Special Care® 24, Similac Stage 1, Similac® NeoSure®, Similac Water (Sterilized) and Pedialyte Electrolyte Solution manufactured at their Columbus facility.
Abbott says this recall does not impact any of their other formula products. They say they will continue to produce Similac formula products “in alternative product sizes and formats for delivery to retail locations, in addition to increased production throughout our global manufacturing network.”
“We take our responsibility to deliver high-quality products very seriously,” Joe Manning, executive vice president of nutritional products at Abbott said in a statement. “We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.”
A Food and Drug Administration spokesperson tells ABC News the agency is “aware” of Abbott’s new recall of Similac products from their Ohio plant, and say they “don’t expect” it to impact overall domestic supply.
The agency spokesperson pointed to how FDA has relaxed their import discretion, allowing foreign formula makers to sell their products on the U.S. market, as the reason they think this latest recall from Abbott shouldn’t have the same kind of drastic impact which the massive one from earlier this year.
“Parents and caregivers have many additional formula options today thanks to FDA’s efforts and those of many of our government partners,” FDA’s spokesperson said, adding they are “more than doubling the number of formula manufacturers” making formula for U.S. infants.
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