FDA Food Recalls

Recalls / Class I

Class IF-1663-2022

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 PediaSure Harvest 1.0 Cal, For Tube Feeding. Complete nutrition blend. 8 fl oz (237mL). UPC 0 70074-67963 1. 24 count case UPC 00070074679624. Shake very well. Store unopened at room temperature. Once opened, reclose, refrigerate, and use within 24 hours. Manufactured for Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219-3034.

Type
Food
Affected lot / code info
EXPANDED 8-10-2022 Lot Code 320184X00 / Best By Date 09/01/2022 Lot Code 330194X00 / Best By Date 10/01/2022 Lot Code 330204X00 / Best By Date 10/01/2022 Lot Code 330204X01 / Best By Date 10/01/2022 Lot Code 330214X00 / Best By Date 10/01/2022 Lot Code 350264X00 / Best By Date 12/01/2022 Lot Code 360274X00 / Best By Date 01/01/2023 Lot Code 360284X00 / Best By Date 01/01/2023 Lot Code 370014X00 / Best By Date 02/01/2023 Lot Code 370024X00 / Best By Date 02/01/2023 Lot Code 380034X00 / Best By Date 03/01/2023 Lot Code 380044X00 / Best By Date 03/01/2023 Lot Code 380054X00 / Best By Date 03/01/2023 Lot Code 380064X00 / Best By Date 03/01/2023 Lot Code 380074X00 / Best By Date 03/01/2023 Lot Code 380074X01 / Best By Date 03/01/2023 Lot Code 390084X00 / Best By Date 04/01/2023 Lot Code 390094X00 / Best By Date 04/01/2023
Quantity
53,818,025 total units

Why it was recalled

Findings and potential for Cronobacter sakazakii and Clostridium botulinum.

Recalling firm

Firm
Lyons Magnus, Inc
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
3158 E Hamilton Ave, Fresno, California 93702-4163

Distribution

Distribution pattern
Nationwide

Timeline

Recall initiated
2022-07-22
FDA classified
2022-08-30
Posted by FDA
2022-09-07
Terminated
2024-07-25
Status
Terminated

Source: openFDA Food Enforcement endpoint. Recall record F-1663-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings.