Exact FDA event identifier

Event 74138

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

Event summary

Timeline bucket: May 10, 2016
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Bayer Health Care 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

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.

drug · product 1 of 1

Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762

D-0977-2016

Recall number: D-0977-2016
Initiated: May 10, 2016
Classification: Class II
Status: Terminated
Recalling firm: Bayer Health Care LLC
Quantity: 37,512 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Labeling; Product Contains Undeclared API (Oxybenzone)

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling; Product Contains Undeclared API (Oxybenzone)

Code information

CV006V9, 2/2018

Distribution pattern

Nationwide