The Recall Desk
ModerateFDA (Drugs)·D-0867-2018·Announced 2018-06-20

MBi Homeopathic Teething Drops Recalled for Lack of Manufacturing Controls

MBi Nutraceuticals is voluntarily recalling homeopathic teething drops and other products due to a lack of adequate controls during manufacturing.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II but is a voluntary precautionary action due to lack of processing controls with no reported illnesses or injuries, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

MBi Distributing Inc. dba MBi Nutraceuticals is voluntarily recalling specific lots of homeopathic products, including Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir. The recall is limited to products within their expiration dates.

The recall is being conducted because the firm identified a lack of adequate controls during the manufacturing process. The source text does not specify the exact nature of the control failures or report any illnesses or injuries associated with these products.

Consumers who have these products should stop using them and contact the manufacturer for further instructions or a refund. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Teething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teething, 1 Fl Ounce glass amber bottle with glass dropper, MBi Nutraceuticals, Lindon, UT 84042. Bar Code: 3 58301 04011 0
Affected units
121

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 15041402
  • No EXP date

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by MBi Distributing Inc. dba MBi Nutraceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same hazard · lack of controls

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