Woodbine, IA, United States
Grato Holdings, Inc. recalls
8 recalls recorded since 2018, most recently on 3 May 2024. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)0
Terminated or completed8
Class I (FDA)0
Terminated Class II Food
- Recall started
- 3 May 2024
- Terminated
- 5 July 2024
- Reason
- Potential microbial contamination (yeast and/or mold).
- Distribution
- Nationwide US and Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- F-1458-2024, F-1459-2024
- Energique Mineral Magic Dietary Supplement, 2 fl. oz (59 ml) bottle.
- BioActive Nutritional MINAPLEX, Botanical Herbal Supplement; 1 Fl. oz. (30 ml) bottle.
Terminated Class III Drugs
- Recall started
- 30 October 2023
- Terminated
- 12 May 2024
- Reason
- Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
- Distribution
- Distributed to one direct account in Florida with possible further distribution out of state.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0099-2024
- V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 32935
Terminated Class II Drugs
- Recall started
- 24 May 2022
- Terminated
- 8 June 2023
- Reason
- Microbial contamination of non-sterile product.
- Distribution
- Nationwide within the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0989-2022, D-0990-2022, D-0991-2022
- Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: RITE AID, 30 Hunter Lane, Camp Hill, PA 17011. NDC 11822-3644-3
- Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-568-15
- Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15
Terminated Class III Drugs
- Recall started
- 18 June 2021
- Terminated
- 18 October 2022
- Reason
- Superpotent
- Distribution
- FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0653-2021
- B-Force, Homeopathic, 1 Fl Oz (30 mL) bottle, Distributed by: BioActive Nutritional, Inc., Melbourne, FL 32935, NDC 43857-0576-1
Terminated Class III Drugs
- Recall started
- 17 September 2020
- Terminated
- 18 October 2022
- Reason
- Labeling: Product Contains Undeclared API; Incorrect formulation
- Distribution
- UT
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0099-2021
- Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologicals, Inc. 469 W. Parkland Drive Sandy, UT 84070. NDC 43742-0756-1.
Terminated Class II Drugs
- Recall started
- 16 July 2020
- Terminated
- 17 September 2022
- Reason
- Labeling: Error on Declared Strength
- Distribution
- One direct account in UT
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1558-2020
- HGH Vitality Homeopathic, 90 tablets, NDC 43742-1299-1, Dist. by Deseret Biologicals, Inc. 469 W. Parkland Drive, Sandy, UT 84070, NDC: 43742-1299-1
Terminated Class III Drugs
- Recall started
- 15 November 2019
- Terminated
- 28 September 2020
- Reason
- Labeling mix-up - Indications on product label are incorrect.
- Distribution
- U.S.A. Nationwide, Israel
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1049-2020
- Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Woodbine, IA 51579, NDC 44911-0411-1
Terminated Class II Food
- Recall started
- 16 April 2018
- Terminated
- 17 August 2018
- Reason
- Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
- Distribution
- Shipped to customers nationwide and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- F-1401-2018, F-1402-2018, F-1400-2018, F-1403-2018
- Energique, Herbal Supplement, Octocom,; Dist. by Energique, Inc. Woodbine, IA 51579
- Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
- Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
- Energique, Dietary Supplement, Enervimin CNCR Focus, Dist. by Energique Inc.. Woodbine, IA 51579
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.