RecallHawk
Class I Recall

Gerber GoodStart SoothePro Infant Formula with Iron. Milk Based Powder. Stage 1, 0 - 12 Months. Nestle Infant Nutrit

Perrigo Nutritionals

Summary

The FDA issued a Class I for Gerber GoodStart SoothePro Infant Formula with Iron. Milk Based Powder. Stage by Perrigo Nutritionals. Reason: Infant Formula has the potential to be contaminated with Cronobacter spp..

Details

Source

Food Recall

External ID

F-0732-2023

Action Date

2023-04-12

Status

Terminated

Category

food

Product Description

Gerber GoodStart SoothePro Infant Formula with Iron. Milk Based Powder. Stage 1, 0 - 12 Months. Nestle Infant Nutrition, Arlington, VA 22209. Packaged in the following sizes: 1. Net Wt 12.4 oz. (351 g) (6 cans per case) UPC 050000-62400 3 2. Net Wt 30.6 oz. (1.91 lb / 867 g) (4 cans per case) UPC 0 50000-49498 9 3. Net Wt 19.4 oz. (1.21 lb/549 g) (4 cans per case) UPC 0 50000-48722 6 4. Product only sold in Canada: 942g (4 cans per case) UPC 0 55000-38369 1.

Lot/Code Info: Gerber Good Start SootheProTM 12.4 oz: Lot 300357651Z - USE BY 04JUL2024 Lot 300457651Z - USE BY 05JUL2024 Lot 300557651Z - USE BY 06JUL2024 Lot 300557652Z - USE BY 06JUL2024 Lot 300757651Z - USE BY 08JUL2024 Lot 300857651Z - USE BY 09JUL2024 Lot 301057651Z - USE BY 11JUL2024 Lot 301057652Z - USE BY 11JUL2024 Lot 301157651Z - USE BY 12JUL2024 Gerber Good Start SootheProTM 30.6 oz: Lot 301357652Z - USE BY 14JUL2024 Lot 301457652Z - USE BY 15JUL2024 Lot 301557651Z - USE BY 16JUL2024 Gerber Good Start SootheProTM 19.4 oz: Lot 301557652Z - USE BY 16JUL2024I

Quantity Affected: 182,888 cans

Reason for Recall

Infant Formula has the potential to be contaminated with Cronobacter spp.

Distribution

Nationwide and Canada.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-03-17

Company

Perrigo Nutritionals

Charlottesville, VA

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 47 food recalls issued in the same week, part of 204 food-related FDA actions this month.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Perrigo Nutritionals) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Perrigo Nutritionals have FDA actions?

This is the only FDA action we have on record for Perrigo Nutritionals in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "F-0732-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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