Class IF-0942-2022

Class I— FDA's most serious classification, issued when there is a reasonable probability that consumption of or exposure to the product will cause serious adverse health consequences or death.

Product

Abbott Similac Alimentum with 2'-FL HMO, Abbott Similac Alimentum HMO, Abbott Alimentum HMO, Abbott Similac Alimentum infant formula, Abbott Similac Alimentum 400g can. 6 cans per case. Item numbers: 6749111 6749117 6749118 6749124 6749134 6749166 6749181 6749199 Retail UPCs: 070074124476 070074124438 0070074124490 070074124414 7703186029294 7501033958175 0070074122427 070074122441

Type: Food
Affected lot / code info: Batches: 36146Z265 34768Z201 35014Z201 36146Z264 35014Z202 36146Z261 29284Z260 32416Z201 34768Z200 36146Z263 27938Z260 29284Z261 32416Z200 35014Z200 36146Z260 36146Z262 27938Z261 29284Z262 34768Z202
Quantity: 34704 cases

Why it was recalled

Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been produced

Recalling firm

Firm: Abbott Laboratories
Notification channel: Press Release
Type: Voluntary: Firm initiated
Address: 100 Abbott Park Rd Bldg Ap8b, N/A, Abbott Park, Illinois 60064-3502

Distribution

Distribution pattern: US Nationwide. Worldwide.

Timeline

Recall initiated: 2022-02-17
FDA classified: 2022-03-30
Posted by FDA: 2022-03-16
Status: Ongoing

Source: openFDA Food Enforcement endpoint. Recall record F-0942-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings.