Recalls / Class II
Class IIF-0328-2024
Product
Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
- Type
- Food
- Affected lot / code info
- Lot No. 45002IP Product No. 67397 Best By 09/01/24
- Quantity
- 226,650 packets (4,533 cartons)
Why it was recalled
Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive
Recalling firm
- Firm
- Abbott Laboratories
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 2900 Easton Square Pl, Columbus, Ohio 43219-6225
Distribution
- Distribution pattern
- Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia
Timeline
- Recall initiated
- 2023-10-31
- FDA classified
- 2023-11-07
- Posted by FDA
- 2023-11-15
- Terminated
- 2024-09-03
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-0328-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings.