FDA Enforcement Weekly: Supplements, Cosmetics & Food The FDA actions that touch your world, from the documents, in plain English. For QA and regulatory teams.

This week: the alfalfa seed lot, traced end to end · Global Mix recalls tejocote for yellow oleander, again · GF Blends: certified gluten-free plantain flour tested far above 20 ppm · kdc/one Chatsworth warning letter · Prolon spread, one allergic reaction, Class II · Saratoga's third allergen recall · four food warning letters · patulin, stones, wheat.

⭐ Item of the week: one seed lot, traced end to end

FDA's enforcement record for September 16 names the seed supplier in the alfalfa sprout outbreak.

International Sprout Holdings, Inc. (Cookeville, TN), trading as International Specialty Supply, recalled 43,799 lbs of alfalfa seed in 50 lb bags, lot SAL2-24JB, for potential E. coli and Salmonella contamination. Class I. Firm initiated August 23, classified September 14. Distributed to wholesale consignees in 16 states, Puerto Rico, Canada, Mexico, Tahiti and Venezuela (H-1341-2026).

What the documents connect to that lot:

• Everything Sprouts, LLC (Minneapolis) recalled alfalfa sprouts under the Everything Sprouts and Calco brands on August 22, lots 222, 223, 225, 226 and 230, sold in Minnesota and Wisconsin from May 27 to August 21. Expanded August 28 to Robust Radish Mix. FDA's outbreak page: "alfalfa sprouts grown by Everything Sprouts, LLC of Minneapolis, MN, is one of the sources of illnesses in this outbreak."
• Berlin Seeds (Millersburg, OH) recalled alfalfa sprouting seed on September 23 in 1/4 lb to 50 lb sizes. The 5 lb and 50 lb bags carry lot code SAL2-24JB, the lot number in the International Sprout Holdings record. Smaller sizes carry no lot code. Sold through its store and website from February 13 to August 23 to customers in 44 states. Berlin Seeds says its supplier told it a spent irrigation water sample from the lot tested positive for E. coli, and that one illness is connected to this seed.
• The outbreak, per CDC (September 1): 55 ill, 4 hospitalized, no deaths, 15 states (FL, IN, IA, KS, MI, MN, NH, NY, NC, ND, PA, SC, SD, WA, WI). Two pathogens, multiple STEC strains and one Salmonella strain. Not declared over.
• FDA's outbreak page (September 15): "FDA's traceback investigation has identified at least one additional sprout grower who received and used the same lot of alfalfa sprout seeds under investigation." And: "The seed supplier to Everything Sprouts, LLC agreed to initiate a recall of the alfalfa seed lot linked to this outbreak."

The seed shipped from February. The first sprout recall came August 22. The seed recall record posted September 16. The retail seed recall came September 23. FDA's instruction to growers and distributors who received the lot: do not use or distribute the seed or any sprouts grown from it.

Verify: H-1341-2026 in FDA's enforcement database. FDA outbreak page. Berlin Seeds announcement. Everything Sprouts announcement. CDC. Register page: enforcementweekly.com/recalls/international-sprout-holdings-inc-20260823/.

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🔴 Supplements: Global Mix recalls tejocote for yellow oleander, for the second time

Global Mix Inc. (Middle Village, NY) recalled Niwali Tejocote Capsules (90 count, lot RM500925) and Niwali Tejocote Pieces (90 day supply, lot RM400925), both expiring 03/03/2028, on September 21. FDA's announcement: "FDA analysis has determined that the products appear to be Thevetia peruviana, or yellow oleander." Samples were collected June 19, 2026. Five units were sold, through eBay.com and Everymarket.com. No illnesses reported.

The record: Global Mix recalled tejocote root products for yellow oleander in April 2024 under four brands, Eva Nutrition, Science of Alpha Mexican, NWL Nutra Mexican, and Niwali Mexican (Class I, F-1390-2024, multi-state distribution). The brand recalled this week, Niwali, is one of the four. openFDA holds 24 enforcement records with yellow oleander as the reason, from 8 firms, the earliest reported 09/2023, the most recent Siluetaya (H-0647-2026, reported April 2026). Global Mix is the only firm in that set to recall a second time.

The announcement describes one method: FDA laboratory analysis of samples collected June 19. It does not say where the samples were collected.

Verify: FDA announcement. 2024 record F-1390-2024 in the enforcement database. Register: enforcementweekly.com/hazards/.

Also this week

• 🔴 A certified gluten-free ingredient failed the test. GF Blends recalled Truly AIP All Purpose Flour (lots 260225, 260610), Truly AIP Bread Mix (lots 260417, 260617) and EAT G.A.N.G.S.T.E.R. Flat Bread Pizza Mix (lots 260327, 260803) on September 18 for undeclared wheat gluten. From the announcement: plantain flour supplied by PMF Global tested positive for gluten at levels "significantly exceeding the FDA's 20 ppm," and the ingredient had been "labeled and certified as gluten-free." Sold nationwide through eatgangster.com, trulyaip.com and Amazon through September 12. No illnesses reported. (FDA announcement)

• 🔴 Warning letter to a contract manufacturer of OTC drug products. kdc/one Chatsworth, Inc. (Chatsworth, CA) received a CGMP warning letter dated September 8, posted September 22, after a March 31 to April 3 inspection. The product type, active ingredient and contaminant are redacted. What the letter says: the firm did not test each batch for an impurity that FDA describes as forming "through a known mechanism" and as "a known carcinogen"; the firm "was aware that your customer voluntarily recalled [redacted] products in Canada" for that contamination; it "did not provide test results to show products still in the market are below the recommended [redacted] levels"; it "failed to adequately investigate viscosity failures obtained during stability testing of distributed OTC drug products"; and a review of warehouse temperature data from April 2025 through March 2026 found a redacted number of weeks above the labeled storage temperature. FDA reviewed the firm's April 24 response to the Form 483 before issuing the letter. The letter is addressed to the manufacturer; the customer whose products were recalled in Canada is not named. (FDA letter)

• 🟡 One confirmed allergic reaction, filed as Class II. L-Nutra Inc. (Culver City, CA) recalled Prolon brand Apulian Almond & Cocoa Spread, 8.47 oz, lot L2755, expiration January 2, 2027, for undeclared cashew, pistachio and hazelnut. Announced August 17; the enforcement record posted September 16 as Class II, 8,529 jars, sold only through ProlonLife.com (H-1335-2026). From the announcement: "testing confirmed the presence of undeclared tree nut allergens," and "L-Nutra has documented one confirmed allergic reaction associated with this product." (FDA announcement)

• 🟡 A chip maker's third allergen recall in openFDA. Saratoga Potato Chips (Fort Wayne, IN) recalled J. Higgs Loaded Bacon and Cheddar Potato Chips, 7.75 oz, best by DEC 11 26 and DEC 18 26, for undeclared soy, on September 16. Sold at Save A Lot stores in Indiana, Kentucky, Ohio, Tennessee and Maryland. Found in "an internal company review." No illnesses reported. openFDA lists two earlier allergen recalls by the firm: J. Higgs Potato Chip Mix, undeclared milk, July 2025 (H-0272-2025, Class II); Kroger BBQ chips, undeclared milk, February 2020 (F-0797-2020, Class I). (FDA announcement)

• 🔴 Gluten-free veggie chips, undeclared wheat, Class I. Exotique Foods Canada (Etobicoke, ON) recalled Momchipz Gluten Free Veggie Chips Broccoli Florets & Cauliflower, 3 oz, best before August 31, 2026, made in Indonesia, 68 cases sold in the US (H-1330-2026, initiated August 7).

• 🟡 Four food warning letters posted September 22. Binh Minh Tofu (San Jose, CA), letter dated August 18, after a March 2 to 6 inspection: cooling of ready-to-eat tofu from about 170°F to 40°F took 3 to 3.5 hours with no documented control; sanitizer concentration wrong after investigators pointed it out; tofu residue on press molds after cleaning; cracked molds; bracelets touching product during packaging; floors worn to aggregate with standing water; multiple label violations. Three FSVP letters, each stating the firm "did not develop, maintain, and follow an FSVP": Accra Supermarket (Worcester, MA), April 10, for yams, ice cream and shelled peanuts; Shouly Import Corp. (Clifton, NJ), June 26, for roasted sesame, feta and baklava, whose response said it had hired an FSVP consultant, which FDA could not evaluate "because you have not provided any supporting documentation"; Ohom Padmaavathii, LLC (Dayton, NJ), July 22, for flour, after inspections in 2020, 2021 and 2022. (Binh Minh Tofu · Accra · Shouly · Ohom)

• ⚪ Also: Wakefern Food Corp. recalled Wholesome Pantry Organic Unsweetened Apple Sauce, 23 oz, best by June 16, 2027, for elevated patulin; the announcement says "the issue was identified through routine monitoring by the FDA"; sold at ShopRite, Price Rite, The Fresh Grocer, Gourmet Garage and Fairway in nine states. Danone USA recalled So Delicious Salted Caramel Cluster non-dairy pints, best by on or before April 3, 2028, for "small stones and other hard objects" in the cashew inclusions, found through consumer complaints. Ferrero USA recalled Fannie May & XO Marshmallow Pixie S'mores, 1,488 units in IA, IL, IN and OH, for undeclared milk and pecans (H-1334-2026, Class II).

📈 Counted, not inferred

Ingredient suppliers named in this week's documents, and what the buyer did with the name: International Sprout Holdings (seed), named by FDA's enforcement record and by lot code on Berlin Seeds' bags. PMF Global (plantain flour), named by GF Blends in its own announcement. Food to Live (moringa), named by The Hampton Grocer in its August announcement, covered last week. Three supplier names in three weeks, each one put in the public record by the customer, not by FDA's enforcement entry.

✅ If you do one thing this week

If you buy sprouting seed, plantain flour, or any ingredient with a gluten-free or allergen-free certificate: pull the certificate of analysis for your current lot and check whether the test it reports is the test the claim depends on. The GF Blends announcement is the case study: the ingredient was certified, and the finished product tested over 20 ppm.

Question this week: has a supplier ever called you first about a positive result? Reply and tell us how it went. We read every answer.

Every action in this issue is on the register at enforcementweekly.com, with recall numbers and source links.

FDA Enforcement Weekly is built from public FDA records by a small team that reads every enforcement action so you don't have to. Not affiliated with the FDA. Unsubscribe · Forward to a colleague who'd want this.

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