Exact FDA event identifier

Event 78139

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

Event summary

Timeline bucket: September 15, 2017
Product types: Food
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Pro Bioteks Laboratories

Dossier provenance

Source snapshots represented here

openFDA Food 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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.

food · product 1 of 1

Bio35, Vitamin-Mineral Omega Oils Trace Minerals Dietary Supplement, 100 Softgel Capsules. UPC 0-26341-12900-2

F-0009-2018

Recall number: F-0009-2018
Initiated: September 15, 2017
Classification: Class II
Status: Terminated
Recalling firm: Pro Bioteks Laboratories
Quantity: 600,000 soft gel capsules

App-derived interpretation

Undeclared allergen reason.undeclared_allergen · v1.0.0

undeclared soy

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Bio-35 has undeclared soy lecithin.

Code information

Lot# 2037055 Exp 06/12/2020

Distribution pattern

Nationwide to AZ, CA, CO, FL, ID, LA, Ml, MN, MO, NM, NV, OR, TX, UT, WA, WY. No foreign/VA/govt/military consignees.