Elevated risk U.S. Food and Drug Administration

Gerber Good Start Powdered Infant formula recall: Potential Cronobacter sakazakii contamination

Recall published 3+ years ago

Potential Cronobacter sakazakii contamination

Gerber Good Start Infant formula & baby food — recalled infant formula & baby food
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Microbial contamination

This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

What the notice says: Potential Cronobacter sakazakii contamination

Why it matters: The product was found, or is suspected, to carry a harmful micro-organism. The agency notice names the specific organism and that detail matters, because the illness it causes and the people most at risk differ from one to the next.

Symptoms and when to call a doctor

Most foodborne infections cause stomach cramps, diarrhoea, nausea and sometimes fever, starting anywhere from hours to weeks after exposure depending on the organism. See a doctor for a high fever, bloody diarrhoea, vomiting that stops you keeping liquids down, diarrhoea lasting more than three days, or signs of dehydration. Infants, pregnant people, adults over 65 and anyone immunocompromised should seek advice earlier.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
March 17, 2023
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Gerber Good Start
Product type
Infant formula & baby food
Reports of harm
Importantly, no distributed product has tested positive for the presence of this bacteria, no adverse events have been reported and no other products manufactured at this facility or any other of Perrigo’s facilities are affected by this recall.

Products covered by this recall

Powdered Infant formula

What the company announced

Dublin, Ireland – March 17, 2023 – Perrigo Company plc is issuing a voluntary recall of certain lots of Gerber® Good Start® SootheProTM Powdered Infant Formula in the U.S. , that were manufactured at the Company’s Gateway Eau Claire, Wisconsin manufacturing facility from January 02, 2023 to January 18, 2023. This product is being recalled out of an abundance of caution due to the potential presence of Cronobacter sakazakii

Importantly, no distributed product has tested positive for the presence of this bacteria, no adverse events have been reported and no other products manufactured at this facility or any other of Perrigo’s facilities are affected by this recall.

Cronobacter sakazakii is a bacteria commonly found in the environment. In most people it causes no symptoms but in some, particularly premature infants, infants under 2 months of age or infants with weakened immune systems fever, poor feeding, excessive crying or low energy as well as other serious symptoms can occur.

This product is sold at retailers across the U.S. Consumers who purchased the product after March 5, 2023 should look for the following Lot Codes and “use by” dates, which can be found on the bottom of the package. No other lot codes are impacted by this recall. Any consumers who purchased product with matching codes should discontinue use and dispose of the product.

Gerber® Good Start® SootheProTM 12.4 oz:

300357651Z – USE BY 04JUL2024

300457651Z – USE BY 05JUL2024

300557651Z – USE BY 06JUL2024

300557652Z – USE BY 06JUL2024

300757651Z – USE BY 08JUL2024

300857651Z – USE BY 09JUL2024

301057651Z – USE BY 11JUL2024

301057652Z – USE BY 11JUL2024

301157651Z – USE BY 12JUL2024

Gerber® Good Start® SootheProTM 30.6 oz:

301357652Z – USE BY 14JUL2024

301457652Z – USE BY 15JUL2024

301557651Z – USE BY 16JUL2024

Gerber Good® Start® SootheProTM 19.4 oz:

301557652Z – USE BY 16JUL2024I

Consumers can request refunds for impacted products and find more information about Gerber® Good Start® by contacting the Gerber Parent Resource Center on behalf of Perrigo at 1-800-777-7690 anytime 24/7. Consumers with any health-related questions should contact their healthcare provider.

This recall is being conducted in consultation with the U.S. Food and Drug Administration (FDA).

For over 130 years, Perrigo has been committed to meeting the needs of consumers—and the quality and safety of our products is our highest priority. We have numerous regulatory approved procedures throughout the manufacturing process to control for Cronobacter sakazakii. Every batch of infant formula is tested to make certain it meets stringent nutritional, safety, quality, and regulatory requirements. As part of our rigorous protocols to protect the safety of families and infants, we are proactively taking this action.

About Perrigo

Perrigo Company plc is a leading provider of Consumer Self-Care Products and over-the-counter (OTC) health and wellness solutions that enhance individual well-being by empowering consumers to proactively prevent or treat conditions that can be self-managed. Visit Perrigo online at www.perrigo.com.

On November 1, 2022, Perrigo acquired Nestlé's Gateway Eau Claire, Wisconsin, plant, along with the U.S. and Canadian rights to the Good Start® infant formula brand. Perrigo operates the Good Start® infant formula brand in the United States and Canada while Nestlé operates the Good Start® infant formula brand for Women Infants and Children (WIC) contracts.

Media Contact

Tim Schramm, (908) 370-4771, E-mail: [email protected]

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 17 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 04JUL2024 300457651Z
  • 05JUL2024 300557651Z
  • 06JUL2024 300557652Z
  • 06JUL2024 300757651Z
  • 08JUL2024 300857651Z
  • 09JUL2024 301057651Z
  • 11JUL2024 301057652Z
  • 11JUL2024 301157651Z
  • 12JUL2024
  • 14JUL2024 301457652Z
  • 15JUL2024 301557651Z
  • 16JUL2024
  • 16JUL2024I

Model or item number

On the rating label, the box or the instruction sheet.

  • March 5, 2023

Package size

Match the net weight or the piece count on the front of the pack.

  • 12.4 oz
  • 30.6 oz
  • 19.4 oz

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Contamination

Gerber Good Start — This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

  1. Stop eating it and keep it separate from other food.
  2. If anyone who ate it is unwell, mention the recall and the date by name when you call a clinician.
  3. Bag and bin it, or return it to the store for a refund.
  4. Clean and sanitise the fridge shelf, container or surface it was stored on.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Remedy named in the notice: Any consumers who purchased product with matching codes should discontinue use and dispose of the product.

Company contact: Perrigo Company plc — Consumers: Gerber Parent Resource Center on behalf of Perrigo, 1-800-777-7690 — Media: Tim Schramm, 908-370-4771, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Gerber Good Start infant formula & baby food recalled?

Potential Cronobacter sakazakii contamination Potential Cronobacter sakazakii contamination

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: best-by date 04JUL2024 300457651Z or 05JUL2024 300557651Z; model number March 5, 2023. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it and keep it separate from other food.

Can I get my money back?

The notice says: Any consumers who purchased product with matching codes should discontinue use and dispose of the product.

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