SupplierRadar

FDA import refusals

FDA import refusals: baby food from Australia

FDA category: Baby (Infant and Junior) Food Products · October 2016 to April 2, 2026

FDA refused 27 baby food shipment lines from Australia between October 2016 and April 2, 2026, 1 of them in 2026; the most refused products were other formula products and milk base infant formula product, most often for LACKS N/C (net quantity statement missing).

Data from FDA public records, last checked .

27
baby food lines refused since October 2016
1
refused so far in 2026
2
firms with the most records, listed below

Baby food refusals from Australia by year

Shipment lines FDA refused each year. The table has the same numbers as the chart.
Bar chart: refusal lines by 2023 to 2026. The same numbers are in the table.01020302023: 22 refusal lines22’232024: 4 refusal lines’242026 (year to date): 1 refusal lines1’26*
* 2026 is year to date, through April 2, 2026.
Refusal lines by year
YearRefusal linesvs prior year
2026 (to date)1
20244-82%
202322

Other formula products refusals from Australia

FDA refused 18 other formula products lines from Australia between October 2016 and April 2, 2026, 67% of the baby food lines.
Other formula products product descriptions refused from Australia
FDA product descriptionLinesShare of baby food
Other formula products, n.e.c., powder formula1866.7%

Recent other formula products refusals

Recent Other formula products refusals from Australia
DateFirmProductCharges
M Vanderhelm N VanderhelmSouthport, AustraliaOther formula products, n.e.c., powder formulaLACK NOTIFFALSESource
The Littleoak Company Pty CoByron Bay, AustraliaOther formula products, n.e.c., powder formulaLACK NOTIFLACKS N/CNUTRIT LBLSource
The Littleoak Company Pty CoByron Bay, AustraliaOther formula products, n.e.c., powder formulaNUTR DEFSource
The Littleoak Company Pty CoByron Bay, AustraliaOther formula products, n.e.c., powder formulaLACK NOTIFLACKS N/CNUTRIT LBLSource
The Littleoak Company Pty CoByron Bay, AustraliaOther formula products, n.e.c., powder formulaLABELINGSource

Milk base infant formula product refusals from Australia

FDA refused 8 milk base infant formula product lines from Australia between October 2016 and April 2, 2026, 30% of the baby food lines.
Milk base infant formula product product descriptions refused from Australia
FDA product descriptionLinesShare of baby food
Milk base infant formula product (0-12 months), powder formula829.6%

Recent milk base infant formula product refusals

Recent Milk base infant formula product refusals from Australia
DateFirmProductCharges
Blend and Pack PTY LTDHallam, AustraliaMilk base infant formula product (0-12 months), powder formulaFALSEHEALTH CSource
Blend and Pack PTY LTDHallam, AustraliaMilk base infant formula product (0-12 months), powder formulaFALSEHEALTH CSource
Blend and Pack PTY LTDHallam, AustraliaMilk base infant formula product (0-12 months), powder formulaFALSEHEALTH CSource
Blend and Pack PTY LTDHallam, AustraliaMilk base infant formula product (0-12 months), powder formulaFALSEHEALTH CSource
The Littleoak Company Pty CoByron Bay, AustraliaMilk base infant formula product (0-12 months), powder formulaFALSELACKS N/CNUTRIT LBLSource

Toddler milk based formula/drink product refusals from Australia

FDA refused 1 toddler milk based formula/drink product line from Australia between October 2016 and April 2, 2026, 4% of the baby food lines.
Toddler milk based formula/drink product product descriptions refused from Australia
FDA product descriptionLinesShare of baby food
Toddler milk based formula/drink product (12-36 months), ready to feed13.7%

Recent toddler milk based formula/drink product refusals

Recent Toddler milk based formula/drink product refusals from Australia
DateFirmProductCharges
Agrana Staerke GmbHWien, AustraliaToddler milk based formula/drink product (12-36 months), ready to feedLACK NOTIFSource

Why FDA refused baby food from Australia

FDA records a charge code on each refused line; one line can carry several.
Most frequent refusal charges for baby food from Australia
Charge codeMeaningLinesShare
LACKS N/CNet quantity statement missing1222%
NUTRIT LBLNutrition information missing from label1120%
FALSEFalse or misleading labeling1018%
LACK NOTIFAdulterated, 801(a)(3), lack of documentation establishing that the infant formula meets all notification…1018%
LABELINGFair Packaging and Labeling Act713%
HEALTH CUnauthorized nutrient content or health claim47%
NUTR DEFThe infant formula appears to adulterated in that it does not provide the nutrients required by 21 CFR 107.10012%

Import alerts for baby food that list Australia firms

Import alerts for baby food listing firms in Australia
AlertCoversRedGreen
40-05Adulterated and misbranded infant formula1

Australia baby food firms with the most FDA records

Counts are FDA records in SupplierRadar's data, not a ranking of quality.
Australia baby food firms with the most FDA records
FirmCityFDA records
The Littleoak Company Pty CoByron Bay21
Blend and Pack PTY LTDHallam4

Latest baby food refusals from Australia

Latest FDA baby food refusals from Australia
DateFirmProductCharges
Agrana Staerke GmbHWien, AustraliaToddler milk based formula/drink product (12-36 months), ready to feedLACK NOTIFSource
Blend and Pack PTY LTDHallam, AustraliaMilk base infant formula product (0-12 months), powder formulaFALSEHEALTH CSource
Blend and Pack PTY LTDHallam, AustraliaMilk base infant formula product (0-12 months), powder formulaFALSEHEALTH CSource
Blend and Pack PTY LTDHallam, AustraliaMilk base infant formula product (0-12 months), powder formulaFALSEHEALTH CSource
Blend and Pack PTY LTDHallam, AustraliaMilk base infant formula product (0-12 months), powder formulaFALSEHEALTH CSource
M Vanderhelm N VanderhelmSouthport, AustraliaOther formula products, n.e.c., powder formulaLACK NOTIFFALSESource
The Littleoak Company Pty CoByron Bay, AustraliaOther formula products, n.e.c., powder formulaLACK NOTIFLACKS N/CNUTRIT LBLSource
The Littleoak Company Pty CoByron Bay, AustraliaOther formula products, n.e.c., powder formulaNUTR DEFSource
The Littleoak Company Pty CoByron Bay, AustraliaOther formula products, n.e.c., powder formulaLACK NOTIFLACKS N/CNUTRIT LBLSource
The Littleoak Company Pty CoByron Bay, AustraliaOther formula products, n.e.c., powder formulaLABELINGSource
The Littleoak Company Pty CoByron Bay, AustraliaOther formula products, n.e.c., powder formulaLABELINGSource
The Littleoak Company Pty CoByron Bay, AustraliaOther formula products, n.e.c., powder formulaLABELINGSource
The Littleoak Company Pty CoByron Bay, AustraliaOther formula products, n.e.c., powder formulaLABELINGSource
The Littleoak Company Pty CoByron Bay, AustraliaOther formula products, n.e.c., powder formulaLABELINGSource
The Littleoak Company Pty CoByron Bay, AustraliaOther formula products, n.e.c., powder formulaLABELINGSource
The Littleoak Company Pty CoByron Bay, AustraliaOther formula products, n.e.c., powder formulaLABELINGSource
The Littleoak Company Pty CoByron Bay, AustraliaOther formula products, n.e.c., powder formulaLACK NOTIFSource
The Littleoak Company Pty CoByron Bay, AustraliaMilk base infant formula product (0-12 months), powder formulaFALSELACKS N/CNUTRIT LBLSource
The Littleoak Company Pty CoByron Bay, AustraliaMilk base infant formula product (0-12 months), powder formulaFALSELACKS N/CNUTRIT LBLSource
The Littleoak Company Pty CoByron Bay, AustraliaOther formula products, n.e.c., powder formulaFALSELACKS N/CNUTRIT LBLSource

Questions about baby food refusals from Australia

How many baby food shipments from Australia did FDA refuse in 2026?
FDA refused 1 shipment line of baby food from Australia in 2026 through April 2, 2026.
Why does FDA refuse baby food from Australia?
FDA records a charge code on every refused shipment line. For baby food from Australia the most frequent are LACKS N/C (net quantity statement missing, 12 lines), NUTRIT LBL (nutrition information missing from label, 11 lines) and FALSE (false or misleading labeling, 10 lines). A charge describes what FDA's reference table says about one shipment line, not about every firm.
Which import alerts cover baby food from Australia?
As of October 25, 2026, the FDA import alerts for this category that list Australia firms are Import Alert 40-05 (1 firm). General food alerts numbered 99-xx can list Australia firms too; see the country page.

Built for the person who signs the FSVP file

Buying baby food from Australia?

Check each Australia supplier against every FDA record in one paste, free for five suppliers. Watch the ones you buy from and get the source the day a record changes.

SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.