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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80042

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

Open FDA event record

Event summary

Timeline bucket
May 04, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Milbar Laboratories, 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

4 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 4

B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA

D-0811-2018
Recall number
D-0811-2018
Initiated
May 04, 2018
Classification
Class II
Status
Terminated
Recalling firm
Milbar Laboratories, Inc.
Quantity
3,477 plastic bottles

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-sterile Product

Code information

Lot: # ET507-0, Exp. 5/27/2019; GU894-8, Exp. 7/20/2010

Distribution pattern

Within the United States and Puerto Rico

drug · product 2 of 4

Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY, NY 10128

D-0812-2018
Recall number
D-0812-2018
Initiated
May 04, 2018
Classification
Class II
Status
Terminated
Recalling firm
Milbar Laboratories, Inc.
Quantity
2,156 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

Code information

Lot #: KU455-2, Exp. 11/09/2020; KU455-6, Exp.11/26/2020

Distribution pattern

Within the United States and Puerto Rico

drug · product 3 of 4

Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.

D-0813-2018
Recall number
D-0813-2018
Initiated
May 04, 2018
Classification
Class II
Status
Terminated
Recalling firm
Milbar Laboratories, Inc.
Quantity
4,815 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

Code information

Lot #: KU455-4, Exp.10/30/2020

Distribution pattern

Within the United States and Puerto Rico

drug · product 4 of 4

MD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz, (88.7mL), MD Professional LLC, Minneapolis, MN

D-0814-2018
Recall number
D-0814-2018
Initiated
May 04, 2018
Classification
Class II
Status
Terminated
Recalling firm
Milbar Laboratories, Inc.
Quantity
14,491 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

Code information

Lot #: KU503-6, KU393-6, Exp. 12/28/2020

Distribution pattern

Within the United States and Puerto Rico