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Lower risk Food recall · FDA · Published May 18, 2017

HIPP Combiotik HA Products Not FDA Approved - Labeling Issue

HIPP recalls several organic baby food products for not being FDA approved and lacking English labels. Consumers should check product details to avoid unsafe items.

🇺🇸 FDA recall #F-2463-2017FoodHIPP ›
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Recalling firm3CS ORGANICS LLC1632 Old Friendship Rd · Rock Hill, SC 29730-8039
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What happened, in plain English

HIPP is recalling multiple organic baby food products because they are not FDA-approved and do not have English labels. This could lead to confusion or safety risks for parents using these products. Read more at govinfonow.com/recall/21249-hipp-combiotik-ha-products-not-fda-approved-labeling-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/21249-hipp-combiotik-ha-products-not-fda-approved-labeling-issue · Updated October 8, 2026 · FDA enforcement record: FDA #F-2463-2017

Cite this page

“HIPP Combiotik HA Products Not FDA Approved - Labeling Issue.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/21249-hipp-combiotik-ha-products-not-fda-approved-labeling-issue. Based on FDA recall #F-2463-2017 (https://api.fda.gov/food/enforcement.json?search=recall_number:%22F-2463-2017%22&limit=1).

Why it’s dangerous

The products lack FDA approval and English labeling, which could cause confusion about ingredients or usage. This might lead to incorrect feeding practices or safety issues for infants.

Who’s affected

Parents and caregivers who purchased HIPP Combiotik HA products for babies. Young children are at higher risk due to potential labeling confusion.

How to tell if you have this one

Check for HIPP Combiotik HA 1, HA 2, or Pre HA products in 500g (4/case) packaging. All lots are affected, so no specific batch numbers are needed.

  • Brand
    HIPP
  • Category
    Food
FDA recall event · 9 products

All 9 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide - Canada, France, Israel & Mexico
Recall numberProduct, codes & lotsQuantity
F-2461-2017HIPP Anti-Reflux AR Bio-Spezialnahrung, 500g (4/case); All Lots25,000 boxes (total)
F-2462-2017HIPP Bio Combiotik 1, Canister, 900g (4/case), HIPP Bio Combiotik 2, Canister, 900g (4/case), HIPP Bio Combiotik 3, Canister, 900g (4/case), HIPP Bio Combiotik 1, 600g (4bx/case), HIPP Bio Combiotik 2, 600g (4bx/case), HIPP Bio Combiotik 3, 600g (4/case), HIPP Bio Compiotik, Pre, 600g (4bx/case), HIPP Comfort Spezialnahrung, 500g (4bx/case); All Lots25,000 boxes (Total)
F-2463-2017HIPP HA Combiotik HA 1, 500g (4/case), HIPP Combiotik HA 2, 500g (4/case), HA Combiotik Pre HA, 500g (4/case), HIPP Combiotic Growing Up Milk 3, 600g (4bx/case); All Lots25,000 boxes (Total)
F-2464-2017HIPP Organic Comb Hungry Infant Milk, 800g (4bx/case), HIPP Organic Comb First Infant Milk, 800g (4bx/case), HIPP Organic Combiotic Follow on Milk 2, 800g (4bx/case), HIPP Organic Good Night Milk from 6 Months, 350g (12cans/case); All Lots25,000 boxes (Total)
F-2465-2017HIPP Tetrapack-Liquid , Single Serve Combiotik Hungry Infant, 200mL (6pk/24cases), HIPP Tetrapak-Liquid, Single Serve Combiotik First Infant Milk, 200mL (6pk/case); All Lots25,000 boxes (Total)
F-2466-2017HOLLE Bio Lait Pour Nourrissons Au Lait De Chevre, Zuigelingenmelk OP Geitenmelbasis, 1, 400g (4/case), HOLLE Bio-Flogemilch Auf Ziegenmilchbasis, 1, 400g (4/case), HOLLE Bio-Folgenmilch Auf Ziegenmilchbasis, 3, 400g (4/case), HOLLE Bio-Folgemich, 2, 600g (3bx/case), HOLLE Bio-Folgemilch, 3, 600g (4bx/case), HOLLE Bio-Folgemilch 4, 600g (4bx/case), HOLLE Bio-Folgemilch Auf Ziegenmilchbasis 2, 400g (6/box), HOLLE Bio Anfangsmilch 1 Von Geburt, 400g (6bx/case); All Lots25,000 boxes (Total)
F-2467-2017HOLLE Bio Zulgelingen Opvolgmelk 2, (3/case), HOLLE Bio Lait de suite, 2, 400g (6/case), HOLLE Bio Lait pour Nourrissons Zulgelingenmelk, 400g (6/case), HOLLE Lait Pour Nourrissons 1er Age Bio, 400g (6/case). HOLLE Bio Lait de Suit Au Lait De Chevre, 400g (6/case) , HOLLE Bio-Kinermilch 4; All Lots25,000 boxes (Total)
F-2468-2017Lebenswert Bioland Anfangsmilch1, 500g (4/case), Lebenswert Bioland Folgemilch 2, 500g (4/case), Lebenswert Bioland Folgemilch 3, 475g (5/case); All Lots25,000 boxes (Total)
F-2469-2017Topfer Lactana Bio 1 Anfangsmilch, 600g (3/case), Topfer Lactana Bio 2, Bio Folgemilch, 600g (3bx/case); All Lots25,000 boxes (Total)
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the product name and packaging to confirm if it's one of the recalled HIPP Combiotik HA items.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide - Canada, France, Israel & Mexico” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 4.2 years after the firm started it.

1. Firm started the recall: May 18, 201712. FDA classified it Class II: Jul 7, 201723. Published in FDA’s Enforcement Report: Jul 19, 201734. FDA terminated the recall: Aug 11, 2021420172021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Are these products safe to use?

The recall states the products are not FDA-approved and lack English labels, so they are not safe for use as intended.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #F-2463-2017 (May 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for F-2463-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA