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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89501

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

Open FDA event record

Event summary

Timeline bucket
January 28, 2022
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Esupplementsales, 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

HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59

D-0561-2022
Recall number
D-0561-2022
Initiated
January 28, 2022
Classification
Class I
Status
Terminated
Recalling firm
Esupplementsales, LLC
Quantity
500 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.

Code information

Lot: 2107, Exp July 2024

Distribution pattern

Nationwide in the USA via Amazon at www.amazon.com