SunOpta Grains And Foods Inc. FDA Record
SunOpta Grains And Foods Inc. has 19 FDA recalls (18 Class I), 40 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "SunOpta Grains And Foods Inc." is on file.
- Latest recall
- F-1258-2023 · Class I · Jun 16, 2023
- Latest inspection
- Sep 3, 2026 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 19 (18 Class I) | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 40 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 4 | 0 | 0 | 0 | 0 |
| 2025 | 2 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 3 | 0 | 0 | 17 | 17 |
| 2022 | 1 | 0 | 0 | 1 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 2 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 3 | 0 | 0 | 1 | 1 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| F-1258-2023 | Class I | 365 Whole Foods Market Organic Whole Strawberries. Net Wt 32 oz (2 lb) 907 g, UPC 0 99482-45713… | Jun 16, 2023 |
| F-1269-2023 | Class I | Good & Gather Mixed Fruit Blend Pineapple Chunks, Sliced Strawberries, Mango Chunks & Sliced… | Jun 16, 2023 |
| F-1257-2023 | Class I | Mango Chunks packaged under the following brand names and sizes. 1. Great Value. Net Wt 16 oz (1… | Jun 16, 2023 |
| F-1260-2023 | Class I | 365 Whole Foods Market Organic Blackberries. Net Wt 10 oz (284g), UPC 0 99482-40605 9. Keep… | Jun 16, 2023 |
| F-1266-2023 | Class I | Good & Gather Mango Strawberry Blend. Whole Strawberries, Mango chunks & Pineapple Chunks. Net Wt… | Jun 16, 2023 |
| F-1256-2023 | Class I | Pineapple Chunks packaged under the following brand names and sizes. 1. 365 Whole Foods Market… | Jun 16, 2023 |
| F-1259-2023 | Class I | Good & Gather Blueberries. Net Wt 48 oz (3lb) 1.36kg UPC 0 85239-04813 9. Keep Frozen… | Jun 16, 2023 |
| F-1270-2023 | Class I | Seasons Choice Tropical Blend, Pineapple, Mango, Strawberries & Papaya. Net Wt 32 oz (2lb) 907g… | Jun 16, 2023 |
| F-1263-2023 | Class I | Great Value Mixed Fruit. Pineppple, Strawberries, Peaches and Mango. Net Wt 16 oz (1 lb) 454g, UPC… | Jun 16, 2023 |
| F-1268-2023 | Class I | Trader Joe's Organic Tropical Fruit Blend, Pineapple, Bananas, Strawberries & Mango. Net Wt. 16 oz… | Jun 16, 2023 |
| F-1267-2023 | Class I | 365 Whole Foods Market Organic Tropical Fruit Medley. Strawberries, Mangoes, Bannas & Pineapples… | Jun 16, 2023 |
| F-1265-2023 | Class I | Good & Gather Triple Berry Blend. Blueberries, Blackberries, & Red Raspberries. Net Wt 48 oz (3lb)… | Jun 16, 2023 |
| F-1271-2023 | Class I | Seasons Choice Mixed Fruit, Strawberries, Pinneapple, Peaches & Mango, Net Wt 32 oz (2lb) 907g… | Jun 16, 2023 |
| F-1264-2023 | Class I | 365 Whole Foods Market Organic Sliced Strawberries & Bananas. Net Wt 32 oz (2 lb) 907g, UPC 0… | Jun 16, 2023 |
| F-1261-2023 | Class I | Cherries packaged under the following brands and sizes: 1. Great Value Dark Sweet Cherries… | Jun 16, 2023 |
| F-1262-2023 | Class I | Good & Gather Organic cherries & berries fruit blend. Blueberries, dark sweet pitted cherries, tart… | Jun 16, 2023 |
| F-0970-2023 | Class I | Organic Pineapple Chunks, Item 4510-000, packed in 30 lb. poly-lined boxes. | May 19, 2023 |
| F-0631-2022 | Class II | Kirkland Signature Organic Soy Non-Dairy Beverage Vanilla; 12- 32 oz. cartons (note- 12 count… | Jan 26, 2022 |
| F-3562-2017 | Class I | Organic Great Value Dark Sweet Cherry Products Pitted, Net Wt 32 Oz (2 lb) 907 g, Distributed by… | Aug 21, 2017 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 3, 2026 | Alexandria, MN | Food/Cosmetics | No Action Indicated (NAI) | 1000520242 |
| Jul 28, 2026 | Midlothian, TX | Food/Cosmetics | No Action Indicated (NAI) | 3007344327 |
| Jun 11, 2026 | Omak, WA | Veterinary | No Action Indicated (NAI) | 3004133763 |
| Jun 8, 2026 | Omak, WA | Food/Cosmetics | No Action Indicated (NAI) | 3033882155 |
| Dec 12, 2025 | Eden Prairie, MN | Food/Cosmetics | No Action Indicated (NAI) | 3012469939 |
| Aug 15, 2025 | Allentown, PA | Food/Cosmetics | No Action Indicated (NAI) | 3009458166 |
| Jul 12, 2024 | Modesto, CA | Food/Cosmetics | No Action Indicated (NAI) | 3007119738 |
| Sep 29, 2023 | Alexandria, MN | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1000520242 |
| Jan 18, 2023 | Alexandria, MN | Food/Cosmetics | No Action Indicated (NAI) | 1000520242 |
| Jan 17, 2023 | Alexandria, MN | Food/Cosmetics | No Action Indicated (NAI) | 2116595 |
| Jul 19, 2022 | Allentown, PA | Food/Cosmetics | No Action Indicated (NAI) | 3009458166 |
| Nov 3, 2020 | Eden Prairie, MN | Food/Cosmetics | No Action Indicated (NAI) | 3012469939 |
| Jan 9, 2020 | Alexandria, MN | Food/Cosmetics | No Action Indicated (NAI) | 2116595 |
| Apr 2, 2019 | Omak, WA | Food/Cosmetics | No Action Indicated (NAI) | 3004133763 |
| Oct 5, 2017 | Blooming Prairie, MN | Food/Cosmetics | No Action Indicated (NAI) | 3004920009 |
| Jun 30, 2017 | Alexandria, MN | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1000520242 |
| Mar 9, 2017 | Allentown, PA | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3009458166 |
| Aug 22, 2016 | Omak, WA | Food/Cosmetics | No Action Indicated (NAI) | 3004133763 |
| May 12, 2016 | Allentown, PA | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3009458166 |
| Jul 1, 2015 | Modesto, CA | Food/Cosmetics | No Action Indicated (NAI) | 3007119738 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1000520242 | Alexandria, MN | 10 | Sep 3, 2026 |
| FEI 3007344327 | Midlothian, TX | 1 | Jul 28, 2026 |
| FEI 3004133763 | Omak, WA | 3 | Jun 11, 2026 |
| FEI 3033882155 | Omak, WA | 1 | Jun 8, 2026 |
| FEI 3012469939 | Eden Prairie, MN | 2 | Dec 12, 2025 |
| FEI 3009458166 | Allentown, PA | 6 | Aug 15, 2025 |
| FEI 3007119738 | Modesto, CA | 3 | Jul 12, 2024 |
| FEI 2116595 | Alexandria, MN | 8 | Jan 17, 2023 |
| FEI 3004920009 | Blooming Prairie, MN | 1 | Oct 5, 2017 |
| FEI 3003304740 | Moorhead, MN | 1 | Apr 9, 2015 |
| FEI 1000520150 | Alexandria, MN | 1 | Feb 3, 2015 |
| FEI 2022406 | South Gate, CA | 3 | Jan 7, 2014 |
SunOpta Grains And Foods Inc. and the FDA: common questions
Has SunOpta Grains And Foods Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "SunOpta Grains And Foods Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has SunOpta Grains And Foods Inc. received an FDA Form 483?
FDA has not published a Form 483 for "SunOpta Grains And Foods Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect SunOpta Grains And Foods Inc.?
The most recent FDA inspection on file ended Sep 3, 2026 at Alexandria, MN and was classified NAI. FDA has 40 inspections of SunOpta Grains And Foods Inc. on file.
Has SunOpta Grains And Foods Inc. had an FDA recall?
Yes. SunOpta Grains And Foods Inc. has 19 FDA recalls on record, 18 of them Class I, the most serious class. The most recent started Jun 16, 2023.
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