U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Safety
  3. Recalls, Market Withdrawals, & Safety Alerts
  4. MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir Due to a Lack of Process Controls
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir Due to a Lack of Process Controls

This recall has been completed and FDA has terminated this recall.

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Read Announcement

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Recall Reason Description
Lack of Adequate Controls
Company Name:
MBI Distributing, Inc.
Brand Name:
Brand Name(s)
MBI Distributing, Inc.
Product Description:
Product Description
Various Homeopathic Products

Company Announcement

MBI Distributing, Inc. is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, to the consumer level. The drug products have been found to be manufactured with a lack of adequate controls.

Risk Statement: Manufacturing products without proper process controls increases the probability that products will vary in strength, quality and purity.  Use of these products could result in an adverse reaction, especially in vulnerable populations such as infants and children. To date, MBI Distributing, Inc. has not received any reports of adverse events related to this recall.

These homeopathic drug products are in liquid oral dosage form and are packaged in sizes from 1 fluid ounce to 8 fluid ounces.

Product/Brand Name

Size

UPC Code
Teething Drops 1 Fluid Ounce 58301-04011
Nausea Drops 1 Fluid Ounce 58301-05711
Intestinal Colic Drops 1 Fluid Ounce 58301-04211
Stomach Calm 8 Fluid Ounces 58301-38414
Expectorant Cough Syrup 8 Fluid Ounces 58301-08214
Argentum Elixir 8 Fluid Ounces 58301-18114
Silver/Zinc Throat Spray 4 Fluid Ounces 58301-18118

These products were distributed nationwide to health care professionals, retail stores, and consumers.

MBI Distributing, Inc. is notifying its distributors and retailers by mail and is arranging for return of all recalled drug products in their possession. Consumers who have recalled product in their possession should stop using and discard the recalled product.

Consumers with questions regarding this recall can contact MBI Distributing, Inc. by calling 801-796-8745 (Monday-Friday 9:00 am-5:00 pm Mountain Time). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company Contact Information

Consumers:
Michelle Jensen
801-796-8745
Back to Top