BETHLEHEM, Pa. — The state Department of Agriculture conducted emergency inspections at 11 retailers in Lehigh and Northampton counties last month relating to an infant formula recalled by the Food and Drug Administration.
None of the locations was found to be out of compliance.
Since August, the FDA has been monitoring cases of infant botulism in babies who consumed ByHeart formula.
ByHeart, the manufacturer of the affected Whole Nutrition Infant Formula products, in a statement said the FDA identified the first infant in the outbreak on Aug. 9, "despite the initial notification to ByHeart" on Nov. 7.
On Nov. 8, the FDA said it was investigating the outbreak with the Centers for Disease Control, the California Department of Public Health, Infant Botulism Treatment and Prevention Program and other state and local partners.
ByHeart issued a voluntary nationwide recall of all formula cans and single-serve "anywhere pack" sticks on Nov. 11, according to the FDA.
A spokesperson confirmed the Pennsylvania Department of Agriculture conducted emergency inspections in Lehigh and Northampton counties tied to the FDA recall of baby formula.
"Pennsylvania Department of Agriculture food safety inspectors conduct audits of retail food outlets the department oversees to help ensure that products recalled by the federal Food & Drug Administration have been removed from shelves," the spokesperson said.
The inspected retailers include:
- Target #2399 (912 Airport Center Drive in Hanover Township, Lehigh County)
- Target #1510 (1600 Cedar Crest Blvd. in South Whitehall Township)
- Target-Starbucks #2609 (749 Krocks Road in Lower Macungie Township)
- Walmart #2145 (2601 Macarthur Road in Whitehall)
- Walmart Super Center #2641 (1091 Millcreek Road in Lower Macungie)
- Whole Foods Market (750 Krocks Road in Lower Macungie)
- Walmart #2252 (3722 Easton-Nazareth Highway in Lower Nazareth Township)
- Walmart #3563 (3926 Linden Street in Bethlehem)
- Wegmans Food Market #094 (3791 Easton-Nazareth Highway in Lower Nazareth Township)
- Wegmans Food Market #097 (5000 Wegmans Drive in Hanover Township, Northampton County)
- Target #2536 (3835 Dryland Way in Lower Nazareth Township)
Inspection reports noted that some locations removed products after the recall, but none still had affected baby formula on store shelves at the time of the inspections.
As of Dec. 3, the FDA said it received reports that the recalled formula was still found on store shelves in multiple states, including several Walmart, Target, Kroger, Acme and Shaw's stores.
In that same late November update, the FDA said nearly 40 infants have suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula across 18 states, including one to two cases in Pennsylvania. All cases involved children who were hospitalized, according to the FDA.
Laboratory confirmation for some cases is ongoing, the FDA says.
"FDA is working with state partners and retailers to ensure an effective recall and immediate removal of these products from store shelves across the country," the agency said. "All ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online."
The FDA recommends parents and caregivers immediately stop using any ByHeart infant formula products and do the following:
- Take a photo or record the information on the bottom of the package.
- Store the container in a safe spot and label the product as "DO NOT USE."
The American Academy of Pediatrics says signs and symptoms of of infant botulism can appear between three and 30 days from the time of consumption.
If children who consumed ByHeart infant formula develop symptoms, the FDA says state health departments may want to collect the formula container for testing. If children do not develop symptoms after 30 days, parents or caregivers should throw the containers out.
Parents or caregivers can also report a product problem through SmartHub and/or complete an electronic or paper voluntary MedWatch form.
Botulism can be fatal, the FDA warns.
The administration says infants who consumed ByHeart formula and experience any of the following symptoms should seek medical attention immediately: constipation, poor feeding, drooping eyelid, sluggish pupils, low muscle tone, poor feeding, difficulty swallowing, weak or altered cry, lethargy, decreased facial expression, respiratory difficulty and possible respiratory arrest.
ByHeart updated its refund policy on Nov. 24 to provide a full refund for all products purchased on ByHeart.com on or after Aug. 1.
Consumers who purchased ByHeart through its retail partners like Amazon or Target should contact the retailer directly.
