When the FDA / NYSAGM Calls: What Food Businesses Need to Know About Product Recalls

For food manufacturers, distributors, and retailers in New York, few calls are more stressful than one from a state or federal regulator raising a problem that may require product to be removed from commerce. Whether the issue is an undeclared allergen, a labeling error, or a contamination concern, how a business responds in the first 24–48 hours can shape everything that follows, including regulatory exposure, customer relationships, and the ultimate cost of resolving the matter.

At Altman & An LLP, we regularly guide food businesses through this process, working alongside the New York State Department of Agriculture and Markets (NYSAGM) and U.S. Food and Drug Administration (FDA) to manage recalls efficiently and protect our clients’ interests. Here’s what every food business should understand.

Recalls Are More Common Than You Think

A food recall doesn’t require a dramatic outbreak or a national headline. In our experience, many recalls originate from something far more routine: a labeling oversight. Common triggers include:

• Undeclared allergens — milk, eggs, tree nuts, peanuts, wheat, sesame, or fish missing from an ingredient list
• Undeclared color additives — such as FD&C Red No. 40 or other certified colors not listed on the label
• Pathogen contamination — Salmonella, Listeria, E. coli, and similar organisms identified through routine sampling
• Physical contamination — foreign material found during inspection
• Labeling violations — inaccurate net weight, failure to properly declare major food allergens, or noncompliant grading claims

Many of these issues are identified not through consumer complaints, but through routine sampling and inspection by NYSAGM or FDA, meaning a business can find itself facing a recall (or even a product seizure) with little advance warning.

The Recall Process Moves Fast — and So Should Your Legal Response

New York’s recall framework involves determining the scope of the affected product, setting the depth of the recall, notifying affected accounts, and issuing a public warning for urgent cases, followed by effectiveness checks and status reports until the matter is formally closed. It is a common misconception that a business must wait for FDA to assign a Class I, II, or III designation before acting. In practice, the opposite is often true: FDA’s own Enforcement Report lists many recalls as “not yet classified,” reflecting the reality that firms frequently begin a voluntary recall before FDA completes its hazard assessment. Classification typically follows once the firm has supplied the information FDA needs to evaluate the risk, so it is not a prerequisite to starting the recall.

Each stage of the process carries its own legal significance:

• Reportable Food Registry (RFR) reporting is a separate legal obligation from recall classification. Under 21 U.S.C. § 350f, a responsible party must report to FDA’s electronic portal as soon as practicable, and no later than 24 hours, after determining that a food meets the statutory “reasonable probability of serious adverse health consequences or death” standard. That determination is the company’s own, and it can arise well before FDA assigns any formal classification. Businesses should not treat RFR reporting as something that only becomes relevant once a Class I label is attached.
• Recall notification letters must meet specific content requirements to be effective and defensible.
• Interstate distribution typically requires coordinated notice to the FDA, in addition to state-level reporting.
• Detention, seizure, embargo, or other restrictions on affected product can involve separate procedures and conditions before the product may be released or otherwise dispositioned.
• Corrective action, whether reformulating a product or correcting a label, needs to be documented and communicated to regulators in a way that protects the business going forward.

A misstep at any of these stages can prolong a recall, increase regulatory scrutiny, or create unnecessary exposure.

What Does “Class” Actually Mean?

Many business owners hear the word “recall” and immediately picture the most severe scenario. In reality, FDA’s three-tier classification system reflects a wide range of risk levels, and most recalls do not involve life-threatening hazards:

• Class I — a reasonable probability that the product will cause serious adverse health consequences or death.
• Class II — the product may cause temporary or medically reversible adverse health consequences, or the probability of a serious consequence is remote.
• Class III — the product is not likely to cause any adverse health consequences, though it may still violate labeling or other regulatory requirements.

Class II recalls are common in practice and cover a broad middle ground, from a mild, reversible reaction to a labeling gap that carries real but limited health risk (an undeclared minor allergen or additive, for example). Understanding the nature and severity of the hazard matters because it affects recall strategy, communications, and other regulatory obligations. Importantly, RFR reporting is governed by its own statutory standard and does not depend on FDA first assigning a recall classification.

Under FDA regulations, a public warning is reserved for urgent situations where other means of preventing use of the product appear inadequate, and it is not an automatic consequence of any particular classification. NYSAGM separately posts food safety consumer alerts for both Class I and Class II recalls, which is a distinct mechanism from an FDA-issued public warning.

Where Legal Counsel Makes the Difference

Early involvement of counsel can help businesses organize their response, communicate consistently with regulators, and address legal issues as they arise. Legal counsel can:

• Serve as a liaison with state and federal regulators, so communications are clear, accurate, and consistent
• Draft and review recall notices, retail notifications, and status reports to ensure they meet regulatory requirements
• Advise on whether reformulation or relabeling is the more practical path to compliance
• Help design lot-coding practices that clearly distinguish corrected product from recalled product
• Coordinate the release of seized product once corrective conditions are satisfied
• Manage documentation and record retention to reduce future liability

A Proactive Approach Pays Off

The businesses that fare best in a recall situation are often the ones that had a plan before they needed one. Under federal preventive controls requirements, many food businesses are already required to maintain a written recall plan, but even where not strictly mandated, having established protocols, updated contact lists, and a relationship with counsel familiar with the process can dramatically shorten the time between “we have a problem” and “the matter is resolved.”

How We Can Help

Altman & An LLP represents food manufacturers throughout New York in recall matters, labeling compliance, and regulatory proceedings before NYSAGM and the FDA. Whether you’re facing an active recall, want to build a recall plan before you need one, or have questions about a labeling or compliance issue, our team is ready to help.

Disclaimer:

This publication is for general informational purposes only and does not constitute legal advice. The information herein may not reflect the most current legal developments and should not be relied upon as a substitute for consultation with qualified legal counsel. Readers should seek professional advice tailored to their specific circumstances.