The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-009-2013·Announced 2012-10-24

Earthborn Products Recalls Colloidal Silver Supplement for Lack of FDA Approval

Earthborn Products is recalling 161 gallons of colloidal silver supplements because the FDA determined the product is misbranded and not generally recognized as safe and effective.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report specific injuries or illnesses, aligning with a moderate severity rating for a regulatory misbranding issue.

Plain-English summary

Earthborn Products, Inc. is recalling 161 gallons of Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement. The product was sold in various sizes, including 2 fl.oz, 8 fl.oz, 16 fl.oz, 32 fl.oz, 64 fl.oz, and 1 gallon containers, and was distributed nationwide.

The recall was initiated because the FDA issued a final rule establishing that over-the-counter drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective. Consequently, the product is considered misbranded as it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

Consumers who have purchased this product should stop using it and contact Earthborn Products for further instructions. The affected lot numbers are 009-22-A011, 011-28-A011, 004-01-A012, 005-24-A012, 007-24-A012, and 008-08-A012.

The recalled product

Product
Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement, sold in a) 2 fl.oz (59.15 mL), b) 8 fl.oz (236.6 mL), c) 16 fl.oz (473.2 mL), d) 32 fl.oz (946.4 mL), e) 64 fl.oz (1.89 L), and f) 1 Gal. (3.78 L), Distributed by: Earthborn Products, San Diego, CA 92103.
Manufacturer
Earthborn Products, Inc.
Category
Drug — OTC Supplement
Hazard

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 (6)

  • Lot #: 009-22-A011
  • 011-28-A011
  • 004-01-A012
  • 005-24-A012
  • 007-24-A012
  • and 008-08-A012.

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · mis labeling

See all →

Similar recalls