Severity
Moderate
PROLIA SOY FLR 200/20 STD BLK, PROLIA SOY FLR 200/70 STD BLK, PROLIA SOY FLR 300/70 NT BLK, PROLIA SOY FLR 100/20 STD 1MT TT, PROLIA SOY FLR 100/90 STD 1500LB TT, PROLIA SOY FLR 100/90 NT 50LB BG, PROLIA SOY FLR 200/20 XTRA 50LB BG NGM, PROLIA SOY FLR 200/20 STD 50LB BG, PROLIA SOY FLR 200/70 STD 50LB BG, PROLIA SOY FLR 200/70 NT 2000LB TT, PROLIA SOY FLR 200/70+15 STD 50LB BG, PROLIA SOY FLR 90 STD 2000LB TT, PROLIA SOY FLR 200/70 NT BLK, PROLIA SOY FLR 200/20 XTRA 50LB BG, PROLIA SOY FLR 1
Reported: May 10, 2023 Initiated: March 30, 2023 #F-0781-2023 40,536,866 lbs units
The recall
Cargill, Inc Corporate Headquarters issued this moderate-severity FDA Food recall — Products with a gluten free claim may contain gluten levels above 20 ppm..
- Moderate
- severity level
- 40,536,866 lbs
- units affected
- Class II
- classification
- May 10, 2023
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-0781-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Food action (record #F-0781-2023) was formally reported on May 10, 2023, with the manufacturer initiating the action on March 30, 2023. It is classified under Moderate severity (Class II), with a current status of Terminated. Cargill, Inc Corporate Headquarters is listed as the recalling firm, operating out of Wayzata, MN. Federal records indicate 40,536,866 lbs units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: Products with a gluten free claim may contain gluten levels above 20 ppm. Distribution data in the federal record shows the product reached: Nationwide United States, Canada, Chile, Costa Rica, Guatemala, Mexico, and United Kingdom. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Food. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 3 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Where this recall sits in the database
Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified moderate severity.
Units Affected
40,536,866 lbs
Related Recalls
6
6 from same agency
Product Description
PROLIA SOY FLR 200/20 STD BLK, PROLIA SOY FLR 200/70 STD BLK, PROLIA SOY FLR 300/70 NT BLK, PROLIA SOY FLR 100/20 STD 1MT TT, PROLIA SOY FLR 100/90 STD 1500LB TT, PROLIA SOY FLR 100/90 NT 50LB BG, PROLIA SOY FLR 200/20 XTRA 50LB BG NGM, PROLIA SOY FLR 200/20 STD 50LB BG, PROLIA SOY FLR 200/70 STD 50LB BG, PROLIA SOY FLR 200/70 NT 2000LB TT, PROLIA SOY FLR 200/70+15 STD 50LB BG, PROLIA SOY FLR 90 STD 2000LB TT, PROLIA SOY FLR 200/70 NT BLK, PROLIA SOY FLR 200/20 XTRA 50LB BG, PROLIA SOY FLR 100/20 STD BB, PROLIA SOY FLR 200/70 STD 50LB BG NGM, PROLIA SOY FLR 200/20 NT 2000LB TT, PROLIA SOY FLR 200/70 2000LB TT NGM; distributed in bulk, bulk bag, and 50 pound paper bags.
Reason for Recall
Products with a gluten free claim may contain gluten levels above 20 ppm.
Details
- Recalling Firm
- Cargill, Inc Corporate Headquarters
- Units Affected
- 40,536,866 lbs
- Distribution
- Nationwide United States, Canada, Chile, Costa Rica, Guatemala, Mexico, and United Kingdom
- Location
- Wayzata, MN
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | F-0781-2023 |
| Date reported | May 10, 2023 |
| Date initiated | March 30, 2023 |
| Recalling firm | Cargill, Inc Corporate Headquarters |
| Units affected | 40,536,866 lbs |
| Distribution | Nationwide United States, Canada, Chile, Costa Rica, Guatemala, Mexico, and United Kingdom |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
PROLIA SOY FLR 200/20 STD BLK, PROLIA SOY FLR 200/70 STD BLK, PROLIA SOY FLR 300/70 NT BLK, PROLIA SOY FLR 100/20 STD 1MT TT, PROLIA SOY FLR 100/90 STD 1500LB TT, PROLIA SOY FLR 100/90 NT 50LB BG, PROLIA SOY FLR 200/20 XTRA 50LB BG NGM, PROLIA SOY FLR 200/20 STD 50LB BG, PROLIA SOY FLR 200/70 STD 50LB BG, PROLIA SOY FLR 200/70 NT 2000LB TT, PROLIA SOY FLR 200/70+15 STD 50LB BG, PROLIA SOY FLR 90 STD 2000LB TT, PROLIA SOY FLR 200/70 NT BLK, PROLIA SOY FLR 200/20 XTRA 50LB BG, PROLIA SOY FLR 100/20 STD BB, PROLIA SOY FLR 200/70 STD 50LB BG NGM, PROLIA SOY FLR 200/20 NT 2000LB TT, PROLIA SOY FLR 200/70 2000LB TT NGM; distributed in bulk, bulk bag, and 50 pound paper bags.. Recalled by Cargill, Inc Corporate Headquarters. Units affected: 40,536,866 lbs.
Why was this product recalled? ▼
Products with a gluten free claim may contain gluten levels above 20 ppm.
Which agency issued this recall? ▼
This recall was issued by the FDA Food on May 10, 2023. Severity: Moderate. Recall number: F-0781-2023.
Where was the recalled product distributed? ▼
Distribution: Nationwide United States, Canada, Chile, Costa Rica, Guatemala, Mexico, and United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (F-0781-2023) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product? ▼
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.
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Recall Context
Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Food, reported May 10, 2023.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).