Abbott PediaSure Harvest 1.0 Cal, For Tube Feeding. Complete nutrition blend.
Lyons Magnus, Inc recalled this product and the FDA reported the enforcement action on 7 September 2022 as Class I. The recall was initiated by the firm. Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- 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.
- UPC
- 070074679631
- Reason for recall
- Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
- Recalling firm
- Lyons Magnus, Inc
- Firm location
- Fresno, California, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-1663-2022
- Quantity
- 53,818,025 total units
- Distribution
- Nationwide
- Initiated
- 22 July 2022
- Reported by FDA
- 7 September 2022
- Terminated
- 25 July 2024
- Firm notified by
- Telephone
- Product codes
- 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
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This is one of 77 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 77 separate recalls, which almost every published figure does, overstates it by a factor of 77. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 77 of them.
- The recall ran for 2.0 years, from 22 July 2022 to termination on 25 July 2024. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The FDA published the enforcement report 7 weeks after the firm began the recall.
- The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.
What this recall was for
Clostridium botulinum
Clostridium botulinum recalls are recalls of the process, not of a test result: the organism produces its toxin without oxygen, so a low-acid food in a sealed container that missed its scheduled process is recalled whether or not toxin was ever found.
A preventive controls plan covers a botulism risk under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 113
- Thermally processed low-acid foods in hermetically sealed containers: the scheduled process, its establishment by a competent authority, and the records proving every container received it.
- 21 CFR 108.35
- Emergency permit control: the registration and process filing a low-acid canned food processor must hold before it may operate.
Other records from Lyons Magnus, Inc
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 78 other records name this firm.
All 79 records for Lyons Magnus, Inc
All 2022 recalls · All FDA food recall data
21 CFR 113 is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.