FDA Food recall · Reported November 15, 2023
Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive
Abbott Laboratories recalled Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets p… - a moderate-severity action.
Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets p… was recalled by Abbott Laboratories in November 15, 2023. Reason: Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food …. Check the official notice for the remedy. Verify recall #F-0328-2024 with the FDA Food before acting.
The recall
Abbott Laboratories issued this moderate-severity FDA Food recall-Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food ….
- Moderate
- severity level
- Class II
- classification
- November 15, 2023
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-0328-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Food - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Food recalls over time
Where this recall sits in its category - 25,457 food recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
Reason for recall
Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | F-0328-2024 |
| Date reported | November 15, 2023 |
| Date initiated | October 31, 2023 |
| Recalling firm | Abbott Laboratories |
| Firm location | Columbus, OH |
| Affected scope | 226,650 packets (4,533 cartons) |
| Distribution | Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nort… |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (F-0328-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Food before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Food and dietary-supplement notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Food · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026