On February 13, 2026, IF Copack LLC (doing business as Initiative Foods) initiated a voluntary recall of a specific lot of Tippy Toes Apple, Pear & Banana Fruit Purée after FDA testing identified elevated levels of patulin, a naturally occurring mycotoxin. The recall applies to a single production lot distributed nationwide (excluding Alaska). No illnesses have been reported.
For food manufacturers and compliance professionals, the recall highlights ongoing FDA surveillance activity and reinforces regulatory expectations for infant and toddler food products.
Recall Summary
Manufacturer: IF Copack LLC d/b/a Initiative Foods
Product: Tippy Toes Apple, Pear & Banana Fruit Purée (two-pack plastic tubs)
Lot Number: 07174
Best By Date: 07/17/2026
UPC: 036800265783
Package Code: INIA0120
Distribution: Nationwide (excluding Alaska); may have reached Guam and Puerto Rico
Reason: Elevated patulin levels identified through FDA testing
Reported Illnesses: None
The issue was identified during FDA sampling conducted under the Total Diet Study program. Following notification, the company initiated a voluntary recall of the affected lot. Consumers were instructed to discontinue use and return or dispose of the product. Retailers were directed to remove affected inventory and follow recall procedures.
Patulin and Regulatory Limits
Patulin is a mycotoxin produced by molds that can grow on damaged fruit, particularly apples. It is considered a foreseeable chemical hazard in apple-based products.
FDA has established a regulatory limit of 50 parts per billion (ppb) for patulin in apple juice and apple-based products, including products marketed to infants and young children. Exceeding this threshold can result in regulatory action or recall.
Elevated exposure may be associated with:
- Gastrointestinal symptoms
- Headache and fever
- Immune suppression
- Potential neurotoxic effects
Because the product category involves infants and toddlers, the regulatory risk profile is heightened.
FSMA and Preventive Controls
Manufacturers of infant and toddler foods operate under the Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule (21 CFR Part 117).
Key requirements include:
Hazard Analysis
Companies must identify reasonably foreseeable hazards, including chemical hazards such as mycotoxins, and determine whether preventive controls are required.
For fruit-based infant products, patulin is a known and documented risk.
Supply-Chain Program
If the hazard is controlled before receipt (e.g., at the supplier level), the manufacturer must implement a supply-chain program that includes:
- Approved supplier verification
- Risk-based evaluation of suppliers
- Documentation of hazard control measures
- Verification activities such as testing or audits
Because patulin originates in raw fruit, supplier oversight is a central compliance issue.
Monitoring, Verification, and Corrective Actions
Manufacturers must maintain documented procedures for:
- Monitoring preventive controls
- Verifying their effectiveness
- Taking corrective actions when deviations occur
If contamination is detected through FDA surveillance rather than internal controls, regulators may evaluate whether the preventive control program was adequately designed and validated.
Legal and Business Risk
Although no illnesses have been reported, recalls involving infant food products carry elevated legal exposure.
Potential risk areas include:
- Product liability claims
- State consumer protection actions
- Retailer indemnification disputes
- Insurance coverage issues
- Increased FDA inspection activity
Voluntary recalls can reduce enforcement escalation. However, FDA may conduct follow-up inspections to assess hazard analysis, supplier verification documentation, and corrective actions.
For companies in high-risk product categories, documentation quality is often determinative during regulatory review.
Broader Industry Implications
This recall reflects several recurring themes in CPG regulatory compliance:
- FDA surveillance programs remain active. The Total Diet Study and related sampling programs continue to identify chemical contaminants.
- Naturally occurring contaminants remain regulatory hazards. “Natural” origin does not mitigate compliance obligations. Mycotoxins must be evaluated and controlled under FSMA.
- Infant and toddler products face heightened scrutiny. Regulatory expectations increase with product vulnerability.
- Single-lot recalls can prompt systemic review. Even limited recalls may lead to broader examination of supplier controls and preventive control validation.
For manufacturers producing fruit-based infant foods, patulin should be treated as a core chemical hazard requiring documented mitigation and verification.
faq (Frequently Asked Questions)
What triggered the Tippy Toes recall?
FDA testing under its Total Diet Study program identified elevated patulin levels in a specific production lot, prompting a voluntary recall by the manufacturer.
What is the FDA limit for patulin?
FDA’s regulatory limit is 50 parts per billion (ppb) for apple juice and apple-based products, including those marketed to infants.
Does a voluntary recall mean enforcement action?
Not necessarily. A voluntary recall indicates corrective action by the company, often in coordination with FDA. However, follow-up inspection and review are common.
Why are infant food recalls treated differently?
Infants and toddlers are considered a vulnerable population. FDA applies heightened scrutiny due to increased sensitivity to contaminants.
What compliance gaps commonly lead to mycotoxin recalls?
Common issues include inadequate supplier verification, insufficient inbound testing, incomplete hazard analysis, and lack of validation of preventive controls targeting chemical hazards.
Regulatory Guidance and Compliance Monitoring
Juris Law Group, P.C. represents food and beverage manufacturers in FDA recall strategy, FSMA hazard analysis, and supplier verification. Our practice focuses on regulatory containment, inspection response, and the implementation of corrective actions to mitigate downstream liability.
To assist legal and compliance teams in monitoring industry trends, we maintain a Recall Tracker. This tool provides real-time data on FDA and USDA enforcement actions, categorized by product type and contaminant.
Visit the Recall Tracker to monitor current enforcement activity and assess category-specific exposure.
