Lower risk Drug recall · FDA · Published November 15, 2019

Grato Holdings Colostat Homeopathic Remedy Labeling Mix-Up Recall

Grato Holdings recalls Colostat homeopathic remedy due to incorrect labeling. This may cause confusion about intended use. Consumers should check product details and contact the manufacturer for clarification.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1049-2020Drug Grato Holdings ›

Lower-risk recall

Labeling mix-up - Indications on product label are incorrect.

Take action

Contact the company

Recalling firmGrato Holdings, Inc.201 Apple Blvd · Woodbine, IA 51579-1503

✎ GovInfoNow plain-language explainer

Grato Holdings is recalling Colostat homeopathic remedy bottles because the product label shows incorrect indications. This labeling mix-up could lead to confusion about how to use the product safely. Read more at govinfonow.com/recall/37693-grato-holdings-colostat-homeopathic-remedy-labeling-mix-up-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/37693-grato-holdings-colostat-homeopathic-remedy-labeling-mix-up-recall · Updated October 5, 2026 · FDA enforcement record: FDA #D-1049-2020

Cite this page

“Grato Holdings Colostat Homeopathic Remedy Labeling Mix-Up Recall.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37693-grato-holdings-colostat-homeopathic-remedy-labeling-mix-up-recall. Based on FDA recall #D-1049-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1049-2020%22&limit=1).

Grato Holdings, Inc. recalled Colostat, a homeopathic remedy, due to incorrect labeling indications, the FDA said on Nov. 15, 2019. The voluntary Class III recall involved 659 bottles distributed nationwide in the U.S. and in Israel.

How to tell if you have it

Brand: Grato Holdings
Product: Colostat, Homeopathic Remedy
Size: 1 fl. oz. (30 mL) per bottle
Alcohol content: 20% Ethanol
Distributor: Energique, Inc., 201 Apple Blvd., Woodbine, IA 51579
NDC: 44911-0411-1
Lot code: Z56673

The hazard

The hazard is a labeling mix-up where indications on the product label are incorrect, according to the FDA.

Context

GovInfoNow's records show Grato Holdings, Inc. has had eight other recalls since Dec. 22, 2015. Other recent recalls of similar products include BioActive Nutritional MINAPLEX Herbal Supplement Recall (May 3, 2024), Grato Holdings V-FORCE Homeopathic Recall (Oct. 30, 2023), and Grato Holdings Homeopathic Ear Drops Recall (May 24, 2022). Other recent recalls of similar products include American Health Packaging Buprenorphine Tablets Recall (Aug. 19, 2026), Sun Pharmaceutical Perampanel 6mg Tablets Recall (June 17, 2026), and American Regent Levocarnitine Injection Recall (April 16, 2026).

How to tell if you have this one

Check for the product name 'Colostat', 1 fl. oz. (30 mL) per bottle, 20% Ethanol, distributed by Energique, Inc. at 201 Apple Blvd., Woodbine, IA 51579. The specific lot number Z56673 and NDC code 44911-0411-1 are also indicators of the recalled item.

Brand
Grato Holdings
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the product name 'Colostat', 1 fl. oz. (30 mL) per bottle, 20% Ethanol, and the lot number Z56673.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “U.S.A. Nationwide, Israel” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 10 months after the firm started it.

Nov 15, 2019Firm started the recall
Mar 20, 2020FDA classified it Class III
Apr 1, 2020Published in FDA’s Enforcement Report
Sep 28, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/37693-grato-holdings-colostat-homeopathic-remedy-labeling-mix-up-recall">Grato Holdings Colostat Homeopathic Remedy Labeling Mix-Up Recall (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1049-2020 (November 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1049-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.