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FDA Food Verify with FDA Food → Moderate Class II Terminated

KAL Brand Amino Acid Complex UPC 021245 51610 1, Product #51610

Reported: October 7, 2015 Initiated: August 27, 2015 #F-3257-2015 9501 bottles units

Nutraceutical International Corporation issued this FDA Food recall on October 7, 2015. Classified as Moderate severity (Class II). Approximately 9501 bottles units are affected. The recall was issued because: Undeclared allergen, casein is a disclosed ingredient, but the word milk not specifically noted on the ingredient list. This recall notice is sourced from official FDA Food enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Food action (record #F-3257-2015) was formally reported on October 7, 2015, with the manufacturer initiating the action on August 27, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Nutraceutical International Corporation is listed as the recalling firm, operating out of Park City, UT. Federal records indicate 9501 bottles units are affected.

The documented reason for this recall is: Undeclared allergen, casein is a disclosed ingredient, but the word milk not specifically noted on the ingredient list Distribution data in the federal record shows the product reached: Nationwide to 34 states. No foreign/VA/govt/military.. 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, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 4 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 11 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.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

9501 bottles

Related Recalls

6

4 from same agency

Product Description

KAL Brand Amino Acid Complex UPC 021245 51610 1, Product #51610

Reason for Recall

Undeclared allergen, casein is a disclosed ingredient, but the word milk not specifically noted on the ingredient list

Details

Units Affected
9501 bottles
Distribution
Nationwide to 34 states. No foreign/VA/govt/military.
Location
Park City, UT

Recall Profile

Structured summary of the FDA Food recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number F-3257-2015
Date reported October 7, 2015
Date initiated August 27, 2015
Recalling firm Nutraceutical International Corporation
Units affected 9501 bottles
Distribution Nationwide to 34 states. No foreign/VA/govt/military.

Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

9501 bottles units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units)
Large-scale (100K – 1M units)
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled?
KAL Brand Amino Acid Complex UPC 021245 51610 1, Product #51610. Recalled by Nutraceutical International Corporation. Units affected: 9501 bottles.
Why was this product recalled?
Undeclared allergen, casein is a disclosed ingredient, but the word milk not specifically noted on the ingredient list
Which agency issued this recall?
This recall was issued by the FDA Food on October 7, 2015. Severity: Moderate. Recall number: F-3257-2015.
Where was the recalled product distributed?
Distribution: Nationwide to 34 states. No foreign/VA/govt/military..
How do I check if my product is affected by a recall?
Check the product description and recall number (F-3257-2015) 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.

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.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • 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)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product 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.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).