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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77859

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
August 01, 2017
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
The Ampt Life, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC.

D-0126-2018
Recall number
D-0126-2018
Initiated
August 01, 2017
Classification
Class I
Status
Terminated
Recalling firm
The Ampt Life, LLC
Quantity
1380 packets

App-derived interpretation

Undeclared allergen reason.undeclared_allergen · v1.0.0
undeclared sildenafil and tadalafil and undeclared milk

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

All lots

Distribution pattern

Nationwide in the USA

Field note

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