BioActive Nutritional MINAPLEX, Botanical Herbal Supplement; 1 Fl. oz. (30 ml) bottle.
Grato Holdings, Inc. recalled this product and the FDA reported the enforcement action on 10 July 2024 as Class II. The recall was initiated by the firm. Potential microbial contamination (yeast and/or mold).
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
- BioActive Nutritional MINAPLEX, Botanical Herbal Supplement; 1 Fl. oz. (30 ml) bottle.
- Reason for recall
- Potential microbial contamination (yeast and/or mold).
- Recalling firm
- Grato Holdings, Inc.
- Firm location
- Woodbine, Iowa, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1459-2024
- Quantity
- 261 bottles
- Distribution
- Nationwide US and Canada
- Initiated
- 3 May 2024
- Reported by FDA
- 10 July 2024
- Terminated
- 5 July 2024
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Lot J28761
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 2 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 2 separate recalls, which almost every published figure does, overstates it by a factor of 2. All 2 of them are listed on this page.
- The recall ran for 2 months, from 3 May 2024 to termination on 5 July 2024. 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 FDA published the enforcement report 2 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.
What this recall was for
Spoilage and mould
A spoilage recall means the food degraded before its date: mould growth, unintended fermentation, swelling or rancidity, usually traced to a seal, a formulation or a storage temperature.
A preventive controls plan covers spoilage 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 117.93
- Warehousing and distribution: storage and transport under conditions that protect food against contamination and against deterioration of the food and its container.
- 21 CFR 117.80(b)(3)
- Time and temperature: holding food at temperatures that do not allow microorganisms to grow, and for no longer than the process allows.
Filed under dietary supplements. A product can sit in more than one.
Every product in this recall
The FDA opened 2 enforcement records for this one recall, one per product code. This page carries all of them; the 1 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2024-07-10 | Energique Mineral Magic Dietary Supplement, 2 fl. oz (59 ml) bottle. | Grato Holdings, Inc. | Potential microbial contamination (yeast and/or mold). | Class II |
Other dietary supplements recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Other records from Grato Holdings, Inc.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 5 other records name this firm.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2024-07-10 | Energique Mineral Magic Dietary Supplement, 2 fl. oz (59 ml) bottle. | Grato Holdings, Inc. | Potential microbial contamination (yeast and/or mold). | Class II |
| 2018-05-16 | Energique, Herbal Supplement, Octocom,; Dist. by Energique, Inc. Woodbine, IA 51579 | Grato Holdings, Inc. | Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration. | Class II |
| 2018-05-16 | Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579 | Grato Holdings, Inc. | Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration. | Class II |
| 2018-05-16 | Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579 | Grato Holdings, Inc. | Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration. | Class II |
| 2018-05-16 | Energique, Dietary Supplement, Enervimin CNCR Focus, Dist. by Energique Inc.. Woodbine, IA 51579 | Grato Holdings, Inc. | Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration. | Class II |
All 6 records for Grato Holdings, Inc.
All 2024 recalls · All FDA food recall data
21 CFR 117.93 is the clause behind this recall, and it is one 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 accessRecall 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.