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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89543

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

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Event summary

Timeline bucket
February 04, 2022
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Junp Hydration 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

MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, ASIN B08Z74KS88

D-0557-2022
Recall number
D-0557-2022
Initiated
February 04, 2022
Classification
Class I
Status
Terminated
Recalling firm
Junp Hydration LLC
Quantity
750 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this 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: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Code information

Lot # 2010291, Exp 01/07/2024

Distribution pattern

Product was distributed nationwide in the USA via Amazon Marketplace