FDA import refusals
FDA import refusals: baby food from Australia
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
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2026 (to date) | 1 | |
| 2024 | 4 | -82% |
| 2023 | 22 |
Other formula products refusals from Australia
| FDA product description | Lines | Share of baby food |
|---|---|---|
| Other formula products, n.e.c., powder formula | 18 | 66.7% |
Recent other formula products refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| M Vanderhelm N VanderhelmSouthport, Australia | Other formula products, n.e.c., powder formula | LACK NOTIFFALSE | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Other formula products, n.e.c., powder formula | LACK NOTIFLACKS N/CNUTRIT LBL | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Other formula products, n.e.c., powder formula | NUTR DEF | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Other formula products, n.e.c., powder formula | LACK NOTIFLACKS N/CNUTRIT LBL | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Other formula products, n.e.c., powder formula | LABELING | Source |
Milk base infant formula product refusals from Australia
| FDA product description | Lines | Share of baby food |
|---|---|---|
| Milk base infant formula product (0-12 months), powder formula | 8 | 29.6% |
Recent milk base infant formula product refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Blend and Pack PTY LTDHallam, Australia | Milk base infant formula product (0-12 months), powder formula | FALSEHEALTH C | Source | |
| Blend and Pack PTY LTDHallam, Australia | Milk base infant formula product (0-12 months), powder formula | FALSEHEALTH C | Source | |
| Blend and Pack PTY LTDHallam, Australia | Milk base infant formula product (0-12 months), powder formula | FALSEHEALTH C | Source | |
| Blend and Pack PTY LTDHallam, Australia | Milk base infant formula product (0-12 months), powder formula | FALSEHEALTH C | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Milk base infant formula product (0-12 months), powder formula | FALSELACKS N/CNUTRIT LBL | Source |
Toddler milk based formula/drink product refusals from Australia
| FDA product description | Lines | Share of baby food |
|---|---|---|
| Toddler milk based formula/drink product (12-36 months), ready to feed | 1 | 3.7% |
Recent toddler milk based formula/drink product refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Agrana Staerke GmbHWien, Australia | Toddler milk based formula/drink product (12-36 months), ready to feed | LACK NOTIF | Source |
Why FDA refused baby food from Australia
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| LACKS N/C | Net quantity statement missing | 12 | 22% |
| NUTRIT LBL | Nutrition information missing from label | 11 | 20% |
| FALSE | False or misleading labeling | 10 | 18% |
| LACK NOTIF | Adulterated, 801(a)(3), lack of documentation establishing that the infant formula meets all notification… | 10 | 18% |
| LABELING | Fair Packaging and Labeling Act | 7 | 13% |
| HEALTH C | Unauthorized nutrient content or health claim | 4 | 7% |
| NUTR DEF | The infant formula appears to adulterated in that it does not provide the nutrients required by 21 CFR 107.100 | 1 | 2% |
Import alerts for baby food that list Australia firms
| Alert | Covers | Red | Green |
|---|---|---|---|
| 40-05 | Adulterated and misbranded infant formula | 1 |
Australia baby food firms with the most FDA records
| Firm | City | FDA records |
|---|---|---|
| The Littleoak Company Pty Co | Byron Bay | 21 |
| Blend and Pack PTY LTD | Hallam | 4 |
Latest baby food refusals from Australia
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Agrana Staerke GmbHWien, Australia | Toddler milk based formula/drink product (12-36 months), ready to feed | LACK NOTIF | Source | |
| Blend and Pack PTY LTDHallam, Australia | Milk base infant formula product (0-12 months), powder formula | FALSEHEALTH C | Source | |
| Blend and Pack PTY LTDHallam, Australia | Milk base infant formula product (0-12 months), powder formula | FALSEHEALTH C | Source | |
| Blend and Pack PTY LTDHallam, Australia | Milk base infant formula product (0-12 months), powder formula | FALSEHEALTH C | Source | |
| Blend and Pack PTY LTDHallam, Australia | Milk base infant formula product (0-12 months), powder formula | FALSEHEALTH C | Source | |
| M Vanderhelm N VanderhelmSouthport, Australia | Other formula products, n.e.c., powder formula | LACK NOTIFFALSE | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Other formula products, n.e.c., powder formula | LACK NOTIFLACKS N/CNUTRIT LBL | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Other formula products, n.e.c., powder formula | NUTR DEF | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Other formula products, n.e.c., powder formula | LACK NOTIFLACKS N/CNUTRIT LBL | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Other formula products, n.e.c., powder formula | LABELING | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Other formula products, n.e.c., powder formula | LABELING | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Other formula products, n.e.c., powder formula | LABELING | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Other formula products, n.e.c., powder formula | LABELING | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Other formula products, n.e.c., powder formula | LABELING | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Other formula products, n.e.c., powder formula | LABELING | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Other formula products, n.e.c., powder formula | LABELING | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Other formula products, n.e.c., powder formula | LACK NOTIF | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Milk base infant formula product (0-12 months), powder formula | FALSELACKS N/CNUTRIT LBL | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Milk base infant formula product (0-12 months), powder formula | FALSELACKS N/CNUTRIT LBL | Source | |
| The Littleoak Company Pty CoByron Bay, Australia | Other formula products, n.e.c., powder formula | FALSELACKS N/CNUTRIT LBL | Source |
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.
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