Class ITerminated · reported 2023-04-12

Gerber GoodStart SoothePro Infant Formula with Iron. Milk Based Powder.

Perrigo Nutritionals recalled this product and the FDA reported the enforcement action on 12 April 2023 as Class I. The recall was initiated by the firm. Infant Formula has the potential to be contaminated with Cronobacter spp.

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
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.
UPC
0500006240032
Reason for recall
Infant Formula has the potential to be contaminated with Cronobacter spp.
Recalling firm
Perrigo Nutritionals
Firm location
Charlottesville, Virginia, United States
Classification
Class I
Status
Terminated
Recall number
F-0732-2023
Quantity
182,888 cans
Distribution
Nationwide and Canada.
Initiated
17 March 2023
Reported by FDA
12 April 2023
Terminated
21 March 2025
Firm notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
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

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 record is the only one the FDA opened for its recall event, so it covers a single product code.
  • The recall ran for 2.0 years, from 17 March 2023 to termination on 21 March 2025. 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 4 weeks after the firm began the recall.
  • Recalls of infant formula or baby food run a median of 10 months, so this one was longer than usual for its category. Infant formula is the most tightly regulated food in the United States because it is frequently the only thing an infant eats, so a nutrient deviation is a hazard in a way it is not in any other product.

Filed under infant formula and baby food and milk and dairy. A product can sit in more than one.

Other infant formula and baby food recalls

These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.

ReportedProductFirmReasonClass
2026-07-08a.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 24.7 OZ (700 G); UPC: 860013251901 b.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 14.1 OZ (400 G); UPC: 860013251918NARA ORGANICS INCProduct may be contaminated with Clostridium botulinum.Class I
2026-06-10a2 Platinum Premium infant formula Milk-based Powder with Iron 31.7oz (900g) Intended use: infant formula (0 12 months). Condition: shelf stable product Type of packaging: metal tin with plastic dust cap. Net weight: 31.7oz (900gm). UPC: 813267020335. Firm name listed on label: The a2 Milk Company. 4909 Pearl East Circle, Suite 300 Boulder CO 80301.The a2 Milk CompanyPossible contamination with Cereulide toxin.Class I
2026-03-11tippy toes apple pear banana 6 months & up baby food 2-4OZ (113g) PACKS NET WT 8 OZ (226g) DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 1-888-423-0139 PRODUCT OF USA UPC: 036800265783IF Holding II, LLCPotential contamination with patulin.Class II
2026-03-04Valley Springs 100% Natural Bottled Water packaged in the following size plastic jug with plastic caps: 1. 1 Gal Net 128 Fl oz. UPC 0 31193-00701 9. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 2. 2.5 Gallon Net (320 Fl oz./9.4L). UPC 0 31193-01501 4. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 3. Infant Water, 1 Gal Net, 128 FL. Oz. Not sterile. Use as directed by physician or by labeling directions for use of infant formula. UPC 0 31193-01401 7. 4. Daisy's Doggy Water, 1 Gal Net, 128 FL. Oz. 100% Pure Water. No Chlorine. UPC 0 31193-90100 3. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. Distributed by DDW LLC, 109 S. Thompson Rd., Sun Prairie, WI 53590.Valley Springs Artesian Gold, LLCWater was bottled under insanitary conditions.Class II
2026-01-28All human food products distributed from the firm. Including but not limited to: snack foods, candy, gum, cooking oil, canned fruit and beans, honey, Dietary supplements, peanut butter, oatmeal, rice, dry peas and beans, ramen, cold cereal, hot sauce, lemon juice, crackers, canned sardines tuna and Oyster, sauces, seasonings, sugar, bottled and canned beverages, coffee and filters and creamer, tea bags, canned pasta, dates, flour, baby foodGOLD STAR DISTRIBUTION INCPotential exposure of rodents and rodent activity in the distribution center.Class II
2025-12-171. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams; Cans sold in 1 pack, 2 packs, 4 packs, or 6 packs 2. ByHeart Whole Nutrition Infant Formula Anywhere Packs Single Serve Packet 17 grams in packages containing 14 Single Serve PacketsByHeart, INC.Contaminated with Clostridium botulinumClass I
2025-06-11Greenwise Pear Kiwi Spinach & Pea Baby Food Pouch. Net Wt 4 oz. (113g). Stage 2 6 months+, Best if" date of 11/01/2025. Packed in 14 pouches per case, 4 oz per pouch. Distributed by Publix Super Markets, Inc. 3300 Publix Corporate Parkway Lakeland, FL 33881.Publix Super Markets, Inc.Elevated levels of Lead, cadmium and arsenicClass II
2024-09-04CVS Health brand and HEB Baby brand Premium Infant Formula with Iron Milk-Based Powder; packaged in 964g composite cans; 4 cans per case; UPC 50428318034 and 41220164578PBM Nutritionals, LLCProduct contains levels of Vitamin D above the maximum level permitted.Class II

All 2023 recalls · All FDA food recall data

Behind every recall is a clause 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 access

Recall 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.