Regulatory & Compliance Brief · Edition 2

How we count.

We use two FDA views. The firm’s announcement appears on FDA’s recalls page, and its row carries no class. The enforcement report lists each product line and its classification. These are two views of overlapping events and we never add them together. When we give you a number we say which view it came from.

• Announcements: every row FDA tags Food & Beverages or Dietary Supplements with a September date. We pulled 19 and excluded exactly one: the row for American Regent, Inc., an epinephrine injection that FDA’s page files under Food & Beverages. 19 minus 1 is 18. No other row is excluded. NEW is an announcement dated September 10 through September 29 inclusive: 13 of the 18. We sort each of the 18 by the reason stated on its row: pathogen 7, undeclared or improperly declared allergen 5, supplement containing a drug ingredient 2, foreign object 2, chemical contaminant 2. All 18 are named below, so you can check the sort.

• Enforcement events: report_date September 1 to 30, grouped by event_id. An event is Class I if any product line in it is Class I: 23 of 48. Of the 48, 46 carry a class; event 99757 is marked Not Yet Classified, and event 99869 is marked Not Yet Classified. We call a Class I event an undeclared-allergen event when its stated reason is an allergen that is undeclared or not declared: 8 of the 23 (event IDs 99368, 99424, 99571, 99575, 99615, 99636, 99644, 99874). The other 15: Salmonella 8 (99538, 99587, 99594, 99611, 99656, 99695, 99830, 99842), E. coli and/or Salmonella 1 (99737), E. coli and Salmonella 1 (99822), E. coli 1 (99831), Listeria monocytogenes 2 (99841, 99853), dried fish not properly eviscerated before drying 1 (99684), and one supplement (98691). The report dates in the data are September 2, 9, 16, 23 and 30: all five weekly reports dated in September. Our October 1 pull held the reports dated September 2 to 23: FDA’s enforcement data had then last updated on September 23. We pulled it again on October 9, after the September 30 report arrived.

• FSIS: the file carries English and Spanish rows: 1,239 English and 789 Spanish. We count distinct notice IDs (field_recall_number) in English rows only: 1,239, of which 1,070 are recalls and 169 are public-health alerts. A September recall is an English row marked Active Recall or Closed Recall with a recall date in September 2026.

• MOVED and closed: we compare our October 1 FSIS save with our saved baseline, whose latest recall and last-modified dates are September 9, field by field, English rows. “Closed” means the record read Active Recall in the baseline and reads Closed Recall on October 1. The FSIS file gives a closure year but no closure date, so we do not state one.

The month so far

18 FDA recall announcements · 13 of them NEW

7 pathogens · 5 allergens · 2 supplements containing drug ingredients · 2 foreign objects · 2 chemical contaminants

23 of 48 FDA enforcement events this month include a Class I product line, the most serious class

Critical · MOVED

The “two-state” pork recall is now a six-state recall

In our last edition (cutoff September 10) we reported that the El Eden Import Distributor Corp recall of ineligible imported pork cracklings, Class I, opened September 9, listed distribution to New Jersey and Utah only. FSIS last modified the record on September 17. It now lists New Jersey, Utah, Massachusetts, New York, Connecticut and Illinois, and it now carries a retail distribution list (RC-021-2026-Retail-List.pdf) that our saved baseline did not.

What this means for your Tuesday

FSIS’s September 17 editor’s note says the release was updated to add the four states and to remove a specific import date, and the release says FSIS’s continuing investigation may identify consignees in more states. It does not say how the added states were identified. MATANGA’s reading, not FSIS’s: a distribution list can change after a notice is published. If your recall response checks a notice once, reads “not my state” and closes the ticket, this is the case that gets past you. We recommend re-checking open recalls on a schedule, and keeping receiving records good enough to answer “did we receive it” in hours whichever states are named. When FSIS attaches retail distribution lists, as it has on three of this month’s five FSIS recalls (each list is named in this brief), check them alongside the recall details and your receiving records.

Confidence: high on the facts. FSIS record, compared field by field against our saved baseline copy of the same record. The comparison is ours, not FSIS’s.

Critical

Two Listeria announcements

Made Fresh Salads Inc., September 6 (earlier this month): ready-to-eat deli style salads and cream cheese. Gias Foods, Inc., September 15 (NEW): Bettergoods Italian Lemon Alfredo Fettuccine. Both announcements give the reason as potential contamination with Listeria monocytogenes. The announcement rows we saved go no further than that. Made Fresh Salads Inc. appears in none of the FDA enforcement reports we pulled, whose report dates are September 2, 9, 16, 23 and 30, so we cannot tell you a class for it. The September 30 report carries a Class I event for Lemon Alfredo Fettuccine from GIAS FOOD INC., with the stated reason “Contamination with Listeria monocytogenes” (event 99853).

What this means for your Tuesday

FDA’s Bad Bug Book says Listeria monocytogenes “can grow at refrigerator temperatures” and notes its “persistence in food-manufacturing environments.” MATANGA’s prompt, not an FDA finding about either firm: if you make, co-pack or buy refrigerated or frozen product, ask when you last looked at your environmental monitoring records.

Confidence: high on both announcements.

Critical

Five allergen recalls, September 8 to 24

FreshPoint Central Florida, Inc., September 8 (earlier this month): egg improperly declared on a cranberry chicken salad wedge sandwich. Whole Foods Market, September 11 (NEW): undeclared egg in a cheese. Saratoga Potato Chips LLC, September 18 (NEW): undeclared soy. GF Blends, September 18 (NEW): undeclared wheat in flour, bread mix and pizza mix products. Deano’s Pasta, September 24 (NEW): undeclared crustacean shellfish (lobster) in a pasta.

What this means for your Tuesday

The FDA rows we saved say what was undeclared or improperly declared. They do not say how the label came to differ from the product, and we are not suggesting a cause at any of these five firms. MATANGA’s view, not FDA’s: across the industry, a common control for undeclared-allergen risk is a label-versus-formula check when an ingredient or supplier changes. We draw no connection to the five recalls above. Separately, in the classified view, 8 of the 23 Class I events this month are undeclared-allergen events (listed in the counting note above).

Confidence: high on the announcements and on the count. The count is our observation, not FDA’s.

Developing

Supplement recalls

SUPPLX.com, September 4 (earlier this month): products containing undeclared yohimbine. A&P Creations LLC, September 15 (NEW): a supplement containing sildenafil and tadalafil. Separately, and not added to those two, the enforcement reports carry one Class I supplement event this month: a product whose stated reason is that it contains 1,4-DMAA, phenylethylamine and phenibut (event 98691).

What this means for your Tuesday

The FDA rows we saved, and the stated reason for event 98691, name the drug ingredients. They do not say how the ingredients got there, and neither do we. MATANGA’s recommendation: if you distribute or white-label supplements, consider whether your receiving tests would detect an undeclared drug ingredient. In our view, identity testing confirms what should be there; finding what should not be there typically takes targeted screening for the drug ingredients known in the category.

Confidence: high. Two firm announcements and one FDA enforcement record.

Developing · NEW

Two chemical contaminant recalls

Wakefern Food Corp., September 22: Wholesome Pantry organic unsweetened apple sauce, elevated levels of patulin. Galil Importing Corp, September 24: Lior ground cinnamon, potential elevated levels of lead. Each announcement states the contaminant. Neither row states a source.

What this means for your Tuesday

MATANGA’s prompt, not an FDA finding about either firm: if you buy spices or fruit purees, check whether your supplier specifications name the chemical contaminants that matter for that ingredient, and how often a result comes back to you. We draw no connection to the two recalls above.

Confidence: high on both announcements.

Also this month

NEW: Evergreen Fresh Sprouts, LLC., broccoli sprouts, potential Salmonella, September 10. Danone USA, a non-dairy frozen dessert that may contain foreign objects such as small stones and other hard objects, September 15. Berlin Seeds, alfalfa sprouting seeds, potential Shiga toxin-producing E. coli and/or Salmonella, September 23. G. L. Mezzetta Inc., Golden Greek peperoncini, may contain foreign objects such as a pest contaminant in the jar, September 26. Sierra Nevada Cheese Company, Sierra Nevada Graziers raw milk Monterey Jack, Jalapeno Jack, medium cheddar and sharp cheddar, potential Shiga toxin-producing E. coli, September 29. The September 30 enforcement report carries a Class I event for the Evergreen Fresh Sprouts broccoli sprouts, Salmonella (event 99842).

Earlier this month: Foods Alive Inc., moringa leaf powder, potential Salmonella, September 4. Frutas y Hortalizas del Sur S.A., Organic Triple Berry Blend, possible E. coli, September 3. Now classified: the enforcement reports now carry a Class I event for each of these two products: Foods Alive organic moringa leaf powder, Salmonella (event 99830), and the Organic Triple Berry Blend, E. coli O145:H28 (event 99831), both in the September 23 report.

Meat, poultry & egg · the other regulator

3 FSIS recalls dated after September 10, all NEW and all Class I. Star Meat Delivery Inc., September 22: raw pork, beef and goat products produced without the benefit of inspection, distribution nationwide, with a retail distribution list (RC-022-2026-Retail-List.pdf). Fontanini Foods LLC, September 25: raw frozen pork sausage, possible foreign matter, distribution California, Florida, Michigan and Nevada. Sempio Food Services Inc., September 25: ready-to-eat chicken stew imported without the benefit of import reinspection, distribution to Florida, Georgia, Illinois, Maryland, New Jersey, New York, Pennsylvania and Virginia.

The month stands at 5, all Class I: these three, the El Eden pork cracklings above, and Prime Line Distributors and Ferrarini USA, imported ready-to-eat pork guanciale, possible Listeria, September 6. FSIS’s summary says the problem was discovered during routine import reinspection testing, when a product sample confirmed positive for Listeria monocytogenes. Changed between our saved files: FSIS last modified the Prime Line and Ferrarini record on September 29, and it now carries two retail distribution lists (RC-019-2026-Retail-List.pdf and RC-020-2026-Retail-List.pdf) that our saved baseline did not.

Closed · Changed between saved files

What a recall actually gets back

Six FSIS records read Active Recall in our saved baseline and Closed Recall in our October 1 save. FSIS publishes the quantity recovered.