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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78791

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

Open FDA event record

Event summary

Timeline bucket
December 14, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SHISEIDO AMERICA INC.

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

5 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 5

bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals Beauty, Inc. SF, CA 94105 USA, NDC 98132-761-01

D-0214-2018
Recall number
D-0214-2018
Initiated
December 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SHISEIDO AMERICA INC.
Quantity
248,661 bottle and /tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.

Code information

SKU#: BE8047201

Distribution pattern

Product was distributed nationwide.

drug · product 2 of 5

Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in a) 2mL, b) 15 mL and c) 50 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022. NDC 58411-256-60

D-0215-2018
Recall number
D-0215-2018
Initiated
December 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SHISEIDO AMERICA INC.
Quantity
N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.

Code information

SKU#: a) 8C52541, b) 8B41841, c) 1155840, 1155841, 1155842, 1155851, 0710341, 0710342

Distribution pattern

Product was distributed nationwide.

drug · product 3 of 5

Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022,

D-0216-2018
Recall number
D-0216-2018
Initiated
December 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SHISEIDO AMERICA INC.
Quantity
N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.

Code information

SKU#: 95167

Distribution pattern

Product was distributed nationwide.

drug · product 4 of 5

Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022

D-0217-2018
Recall number
D-0217-2018
Initiated
December 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SHISEIDO AMERICA INC.
Quantity
N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.

Code information

SKU#: 95393

Distribution pattern

Product was distributed nationwide.

drug · product 5 of 5

Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022, NDC 58411-256-60

D-0218-2018
Recall number
D-0218-2018
Initiated
December 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SHISEIDO AMERICA INC.
Quantity
N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.

Code information

SKU#: 95284

Distribution pattern

Product was distributed nationwide.