FDA Drug recall D-0126-2018
NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912)
- FDA Drug
- Class I
- terminated
- Published 2017-12-27
On 2017-12-27 the FDA classified a Class I recall of NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912) by The Ampt Life, citing marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0126-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-08-01 |
| Published | 2017-12-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | The Ampt Life |
| Distribution | US |
Product
NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC.
Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0126-2018%22
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