Off the Shelves

Every recall in the Enforcement Report lands on the same three-rung ladder. Class I means a reasonable probability of serious harm or death. Class II means temporary or reversible harm; Class III, little chance of any. The ladder is the report's whole editorial judgment, and it is where this page starts: food carries the largest serious-harm load by far - roughly one food recall in three is Class I, against about one in eight for drugs and devices.

Stream	Class I	Class II	Class III	Total
Drug	2,100	13,800	1,873	17,773
Food	9,600	16,900	2,716	29,216
Device	5,100	30,200	4,130	39,430

The record explains itself, in free text: every recall carries a reason_for_recall, here themed into recurring buckets across the Class I subset. The pattern is banal and that is the point. The most-serious recalls are rarely exotic - they are a label that forgot the milk, a line that grew Listeria, a vial that was never sterile. Food fails at the label and the line; drugs fail at sterility and dose; devices fail in software.

1. 01
   Undeclared allergen Food 4,200
2. 02
   Microbial contamination (Listeria, Salmonella) Food 3,100
3. 03
   Lack of sterility assurance Drug 1,450
4. 04
   Foreign material / particulate Food 980
5. 05
   Software or firmware malfunction Device 720
6. 06
   Super- or sub-potent formulation Drug 610
7. 07
   Component or mechanical defect Device 520
8. 08
   Cross-contamination with another drug Drug 430

Fig. 2Class I recalls attributed to each themed reason, ranked. The chip names the stream the theme dominates; the printed count carries the value. Counts are illustrative stand-ins.

The most-serious tier is not flat. Over the last decade Class I volume rose in all three streams - food up roughly 80 percent, devices more than doubling, drugs grinding steadily upward. The three panels share one vertical scale, so the heights compare directly across the gutter: food dwarfs the other two, and keeps pulling away.

Fig. 3Class I recalls per report year, one panel per stream, shared vertical scale. The delta compares 2016 to 2025. Yearly counts are illustrative stand-ins.

○ Illustrative 2025 is a partial reporting year; the dip in the latest point reflects lag, not a decline.

Rising volume could just mean more products and better surveillance. The sharper question is the mix: of what each stream recalls, how much sits on the top rung? That share rose in all three streams over the decade - food most steeply, from roughly 28 percent to 36. The ladder is not just busier; it is tilting toward Class I.

Stream	2016	2025	Change
Drug	9.1%	13.4%	+4.3 pp
Food	27.8%	36.2%	+8.4 pp
Device	10.7%	14.8%	+4.1 pp

○ Illustrative Share of the stream's own records, so a stream can grow safer in absolute terms while its mix worsens - and the reverse.

The filing rate breathes with the year. Class I volume crests in high summer - peak produce, peak heat, peak Listeria - and eases through the winter, when the dominant failure shifts from the pathogen to the label. The swing is about 50 percent, trough to peak: seasonality, not noise.

Monthly table

Month	Class I / mo
Jan	150
Feb	140
Mar	155
Apr	160
May	175
Jun	195
Jul	210
Aug	205
Sep	185
Oct	170
Nov	165
Dec	150

○ Illustrative Averaging over full years removes the partial-year lag that would sag the tail months.

Every enforcement record names the recalling firm and where it sits. Mapped that way, a recall is a return address: the record piles up where things are made - California, the mid-Atlantic drug belt, the industrial Midwest - not where they are eaten, swallowed, or implanted. Foreign and blank-state records are excluded. Darker states carry more records; the ranked table below is the source of truth.

○ Illustrative Counts are raw record volume, not per-capita; big-population, high-manufacturing states dominate by construction.

Big manufacturing states file the most recalls - that is Fig. 6, and it is mostly a census of factories. Divide instead: of each state's records, how many sit on the top rung? The answer scatters. New Jersey and Massachusetts run well above the national 17.3 percent line; Wyoming sits far below it. A state can be a heavy filer with a mild mix, or a light filer whose record skews serious.

○ Illustrative Small states ride on few records, so their shares swing hardest - read the left edge of the plot loosely.

The recall system runs on confession. Across all three streams just 3.8% of recalls are FDA-mandated; the rest are firms pulling their own products before the agency compels them. That is the design working - and it is also the design's exposure, because the ledger only records the failures firms notice and admit to. The rose slice marks the rare forced action.

Fig. 8Recall initiation per stream: the neutral track is voluntary, the rose slice is FDA-mandated (drawn at a minimum visible width; the printed share is exact). Split is an illustrative stand-in.

○ Illustrative FDA gained mandatory food-recall authority only in 2011 (FSMA); most mandated actions post-date it.

Termination is the FDA's word for over: the agency has verified the product is off the market and the fix held. It is slow. Of the terminated records, roughly 64 percent stayed open longer than a year, and the single most common outcome is one to two years on the books. Devices close slowest - a firmware fix must be verified unit by unit; a contaminated lot of food just has to be gone.

Open span	Records	Share
under 6 mo	9,400	14%
6-12 mo	15,800	23%
1-2 yr	21,400	31%
2-3 yr	12,600	18%
3-5 yr	7,300	10%
5+ yr	3,100	4%
All terminated	69,600	100%

○ Illustrative Ongoing recalls are excluded by construction, which biases these spans short - the still-open tail hasn't finished growing.

Recalls cluster. A minority of firms account for a repeated share of events, usually for the same recurring failure - the compounding pharmacy that cannot hold sterility, the bakery group that keeps losing track of its allergens. These rows are illustrative archetypes, deliberately unnamed: pinning a stand-in count on a real company would be a smear. The real ranking, with real names, arrives with the bulk ingest.

#	Firm (archetype)	Stream	Worst class	Events
01	Compounding Pharmacy (regional)	Drug	Class I	41
02	Packaged Bakery Group	Food	Class I	33
03	National Generics Manufacturer	Drug	Class I	29
04	Fresh Produce Packer	Food	Class I	27
05	Infusion Device Maker	Device	Class I	22
06	Dietary Supplement Blender	Food	Class I	19
07	Patient Monitor OEM	Device	Class II	16
08	Sterile Injectables Plant	Drug	Class I	14

Table 1Firms ranked by recall events, with the worst hazard class each reached. Every row is an archetype with a stand-in count, never a named company.