Class IITerminated · reported 2025-11-19

Product Name: Nutra Calm Package: 175cc HDPE Bottle. Type: Vegetable Capsule Count: 90…

Professional Botanicals, Inc. recalled this product and the FDA reported the enforcement action on 19 November 2025 as Class II. The recall was initiated by the firm. Products contains Magnesium Salicylate.

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product
Product Name: Nutra Calm Package: 175cc HDPE Bottle. Type: Vegetable Capsule Count: 90, Dose: 2 Capsules. Product Sku: PB248
Reason for recall
Products contains Magnesium Salicylate.
Firm location
Ogden, Utah, United States
Classification
Class II
Status
Terminated
Recall number
H-0181-2026
Quantity
452 Bottles
Distribution
Distributed nationwide: AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WY.
Initiated
18 June 2025
Reported by FDA
19 November 2025
Terminated
31 December 2025
Firm notified by
E-Mail
Product codes
Lot #: 71527

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

  • Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
  • The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
  • This is one of 3 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 3 separate recalls, which almost every published figure does, overstates it by a factor of 3. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 3 of them.
  • The recall ran for 6 months, from 18 June 2025 to termination on 31 December 2025. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
  • The distribution pattern names 44 states, and the FDA published the enforcement report 5 months after the firm began the recall.
  • Recalls of a dietary supplement run a median of 15 months, so this one was shorter than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.

Named in the distribution pattern: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, Wyoming. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

Filed under dietary supplements. A product can sit in more than one.

Other dietary supplements recalls

These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.

ReportedProductFirmReasonClass
2026-09-02Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404Byron White Formulas, Inc.Label does not declare walnuts in EnglishClass II
2026-09-02Addall XR Shot 1 single bottle, 2 fl. oz., liquid dietary supplementZMB EnterprisesThe product contains 1,4-DMAA, Phenylethylamine and Phenibut.Class I
2026-09-02Byron White FORMULAS A-P Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404Byron White Formulas, Inc.Label does not declare walnuts in EnglishClass II
2026-09-02Byron White FORMULAS A-L Complex Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404Byron White Formulas, Inc.Label does not declare walnuts in EnglishClass II
2026-08-12Zen Principle Naturals Moringa Leaf Powder dietary supplement, 900mg capsules, 180 capsules per PET white bottle. Intended Use: take 2 capsules per day. Route of Administration: OraI. Manufactured for Zen Principle 774 Mays Blvd Incline Village, NV 89451. The product is offered as a 1-pack (180 capsules; Amazon code/FNSKU X000ZJJ4FT) and as a 2-pack (twin pack, 360 capsules; Amazon code/FNSKU X00159YJXP).FACTORY6, INC.Possible Salmonella in Moringa Leaf Powder product.Class I
2026-08-12"***Hondashi 0.25oz***" seasoning packed in silver plastic/metallic pouch, pouches packed in brown paperboard cartons (600 packets/carton), Carton label reads in part as "***Hondashi 0.25oz*600bags/ctn, Ingredients: salt, sodium glutamate, bonito, cornstarch, maltodextrin, water, flavored sodium nucleotide, glucose, soybean protein powder Allergen: Soybean, 1025 Ave S, Ste 150, Grand Prairie, TX 75050***"Pack'n Fresh LLCAllergen missing from contains statement: fishClass II
2026-08-05Mellish Island Super Skin; Dietary Supplement; 60 Capsules, 2 per day; Distributed by Mellish Island Corp. UPC: 8 58792 00332 3Mellish Island CorpFirm's finished product label does not declare the source of marine collagen which was determined to be fish.Class II
2026-07-29Vintage Roots Root Beer Syrup, packaged in glass bottle. Net Wt. 8oz. (236.6 mL). Distributed by Vintage Roots, PO Box 12, Brady, MT 59416. The product label declares: Ingredients: Filtered Water, Pure Cane Sugar, Sassafras Bark, Burdock Roots, Wild Cherry Bark, Molasses, Fresh Lemon Juice, Star Anise, Coriander Seeds, Whole Clove, Wintergreen Extract (no alcohol).Vintage Roots LLCUnapproved food additive: sassafras bark.Class II

Other records from Professional Botanicals, Inc.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event.

All 3 records for Professional Botanicals, Inc.

All 2025 recalls · All FDA food recall data

Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.