Colloidal Silver — Class II drug recall D-009-2013
Terminated recall by Earthborn Products, Inc., reported 2012-10-24, distributed nationwide. Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establis
| Recall number | D-009-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Earthborn Products, Inc., San Diego, CA, United States |
| Recall initiated | 2012-10-05 |
| Classified | 2012-10-18 |
| Reported by FDA | 2012-10-24 |
| Terminated | 2013-02-28 |
| Distributed | Nationwide (US) |
| Quantity | 161 gallons |
| Reason classes | labeling, unapproved product |
| Lot numbers | 004-01-A012, 005-24-A012, 007-24-A012, 008-08-A012, 009-22-A011, 011-28-A011 |
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.
Reason for recall
Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-009-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.