CLASS II Drug recall · Reported 24 Oct 2012 · FDA Enforcement Report
Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement recalled
Earthborn Products is recalling Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement, distributed nationwide in the US. The recall was initiated on 5 Oct 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-009-2013
- FDA event ID
- 63406
- Recalling firm
- Earthborn Products, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Oct 2012
- FDA classified
- 18 Oct 2012
- Reported
- 24 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
Timeline
| 5 Oct 2012 | Recall initiated by company | |
| 18 Oct 2012 | Classified by FDA | +13 days |
| 24 Oct 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Is Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement recalled?
Yes. Earthborn Products recalled Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement on 5 Oct 2012. The recall is Class II and its status is Terminated. Recall number D-009-2013.
Why was it recalled?
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.
Which lots are affected?
Lot #: 009-22-A011, 011-28-A011, 004-01-A012, 005-24-A012, 007-24-A012, and 008-08-A012.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.