Process deviation in FDA food recalls

306 of the 29,386 FDA food recall records published since 2012 name a process deviation. That is 1% of every food recall the agency has reported, and 10 of them are Class I. Data last updated 2 September 2026.

Records of 29,386

306

Share of all recalls

1%

Class I of 306

10

Reported between

2013 to 2026

What is different about these records

The hazard that separates Process deviation from the national picture is clostridium botulinum: 15.4% of these records name it, against 1.2% of all FDA food recalls.

By product, Process deviation is weighted toward ice cream and frozen desserts: 17% of the records here against 5.9% across the corpus.

Recalls involving process deviation skew less severe than the corpus: 3.3% are Class I against 44% nationally.

A single recall here covers far more records than usual: 5.8 enforcement records per FDA event, against 3.7 across the corpus. The agency opens one record per product code, so this is a sign of broad product lines rather than of repeated failures.

The volume is rising: 100 records in the three years to 2025, against 70 in the four before them. A rise in records is not the same as a rise in hazards.

What Process deviation means in a recall record

A process deviation recall means the process ran outside its validated limits: a thermal process that did not reach its time and temperature, a pH that drifted, or a seal that failed.

The firm with the most records of this kind is Kilby Cream, with 35. A high count usually reflects one event split across many product codes rather than many separate failures, which is why the table below is ordered by date rather than by firm.

The clause this maps to

A preventive controls plan covers a process deviation under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.

21 CFR 113

Thermally processed low-acid foods in hermetically sealed containers: the scheduled process, its establishment by a competent authority, and the records proving every container received it.

21 CFR 114

Acidified foods: the controls on equilibrium pH at or below 4.6, and the process that achieves it.

21 CFR 117.150

Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.

By year

Counts are by the date the FDA reported the enforcement action. That date runs behind the date a firm started a recall, so the most recent year is always partial.

Firms with the most records

A firm appears here because it reported recalls, which is what a working recall procedure produces. A high count frequently reflects a single event split across many product codes rather than many separate failures.

• Kilby Cream35
• Dollar General Corporation24
• Urban River Spirits24
• Snapchill, LLC20
• Barron County Organics17
• United Natural Foods, Inc.15
• Skipanon Brand Seafoods LLC15
• Joy Gourmet Foods LLC.14
• Reser's Fine Foods, Inc.14
• LIQUID BLENZ CORP13
• Abbott Laboratories12
• Sysco Atlanta, LLC12

Where the recalling firms are

The state is the location of the recalling firm, not where the product was sold. Distribution is recorded separately on each record.

• Oregon57
• Wisconsin41
• Maryland35
• New York31
• Tennessee25
• Ohio21
• New Hampshire15
• California13
• Georgia12
• Texas11
• Nevada10
• Pennsylvania8

Most recently reported

Questions

How many FDA food recalls involve process deviation?

306 of the 29,386 FDA food recall records published since 2012 name a process deviation, which is 1% of all of them. 10 are Class I, the class the FDA uses when there is a reasonable probability of serious health consequences or death.

What is Process deviation?

A process deviation recall means the process ran outside its validated limits: a thermal process that did not reach its time and temperature, a pH that drifted, or a seal that failed.

Which clause covers a process deviation?

A preventive controls plan under 21 CFR 117 covers a process deviation under 21 CFR 113, 21 CFR 114, 21 CFR 117.150. Thermally processed low-acid foods in hermetically sealed containers: the scheduled process, its establishment by a competent authority, and the records proving every container received it. This is where the control belongs; a recall record states a reason rather than a regulatory finding, and most FDA food recalls are initiated by the firm itself.

All FDA food recall data