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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78589

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 17, 2017
Product types
Food
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Pure Encapsulations, Inc.

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

Complete imported group

Every recalled product in this event

2 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 2

Pure Encapsulations Systemic Enzyme Complex DIETARY SUPPLEMENT 180 CAPSULES UPC: 7 66298 00862 2

F-0396-2018
Recall number
F-0396-2018
Initiated
November 17, 2017
Classification
Class III
Status
Terminated
Recalling firm
Pure Encapsulations, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product contains undeclared sulfites.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Product contains undeclared sulfites.

Code information

All lots within expiry. Lot/Serial Number: 50074561 50085867 50102085 50107811 50113681 50117860 50121029 50122279 50123772 50129551

Distribution pattern

NH, AZ, CO, OH, NC

food · product 2 of 2

pure encapsulations AI Enzymes DIETARY SUPPLEMENT 120 CAPSULES UPC: 7 66298 00318 4 and 60 CAPSULES UPC: 7 66298 00317 7

F-0397-2018
Recall number
F-0397-2018
Initiated
November 17, 2017
Classification
Class III
Status
Terminated
Recalling firm
Pure Encapsulations, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product contains undeclared sulfites.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Product contains undeclared sulfites.

Code information

All lots within expiry. AI Enzymes 120: 50048025 50058242 50063516 50067188 50076912 50080121 50092381 50092382 50104459 50108093 50114435 50118464 50125714 AI Enzymes 60: 50048027 50058243 50063517 50067189 50080122 50097606 50104460 50108094 50114436 50118465

Distribution pattern

NH, AZ, CO, OH, NC