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Johnson & Johnson Consumer, Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Johnson & Johnson Consumer, Inc. has 26 FDA recalls (2 Class I), 8 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Johnson & Johnson Consumer, Inc." is on file.

What these totals cover: FDA records filed under the name "Johnson & Johnson Consumer, Inc." and its spelling variant "Johnson And Johnson Consumer".

Latest recall: D-0834-2021 · Class II · Jul 14, 2021
Latest inspection: Mar 24, 2021 · VAI
Latest 510(k): Jun 19, 2018

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	26 (2 Class I)	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	2	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	8	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Johnson & Johnson Consumer, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	Recall records	Class I
2026	0	0	0
2025	0	0	0
2024	0	0	0
2023	0	0	0
2022	0	0	0
2021	1	20	2
2020	1	0	0
2019	0	0	0
2018	0	0	0
2017	0	6	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

26 recall records from Dec 18, 2017 to Jul 14, 2021. Showing the 20 most recent. View all 26 recall records

Number	Class	Product	Date
D-0834-2021	Class II	Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%)…	Jul 14, 2021
D-0848-2021	Class II	Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone…	Jul 14, 2021
D-0847-2021	Class II	Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%)…	Jul 14, 2021
D-0845-2021	Class I	Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone…	Jul 14, 2021
D-0841-2021	Class II	Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone…	Jul 14, 2021
D-0849-2021	Class II	Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone…	Jul 14, 2021
D-0844-2021	Class I	Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone…	Jul 14, 2021
D-0840-2021	Class II	Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%)…	Jul 14, 2021
D-0839-2021	Class II	Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzone (3%), Homosalate…	Jul 14, 2021
D-0833-2021	Class II	Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRUM SPF 30, Avobenzone…	Jul 14, 2021
D-0837-2021	Class II	Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45, Avobenzone (3%), Homosalate (10%)…	Jul 14, 2021
D-0831-2021	Class II	Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60, Avobenzone (3%), Homosalate…	Jul 14, 2021
D-0843-2021	Class II	Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60+, Avobenzone (3%)…	Jul 14, 2021
D-0832-2021	Class II	Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%)…	Jul 14, 2021
D-0846-2021	Class II	Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone…	Jul 14, 2021
D-0835-2021	Class II	Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%)…	Jul 14, 2021
D-0842-2021	Class II	Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50, Avobenzone 2.7%…	Jul 14, 2021
D-0850-2021	Class II	Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone…	Jul 14, 2021
D-0836-2021	Class II	Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%)…	Jul 14, 2021
D-0838-2021	Class II	Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate…	Jul 14, 2021

Recent FDA inspections

8 inspections from Jul 9, 2010 to Mar 24, 2021.

Date	Site	Product	Classification	FEI
Mar 24, 2021	Lancaster, PA	Drugs	Voluntary Action Indicated (VAI)	1000150647
Mar 11, 2020	Los Angeles, CA	Drugs	No Action Indicated (NAI)	2010632
Oct 8, 2015	Los Angeles, CA	Drugs	Voluntary Action Indicated (VAI)	2010632
Mar 27, 2015	Lancaster, PA	Drugs	Voluntary Action Indicated (VAI)	1000150647
Aug 30, 2013	Lancaster, PA	Drugs	Voluntary Action Indicated (VAI)	1000150647
May 16, 2013	Los Angeles, CA	Drugs	No Action Indicated (NAI)	2010632
Aug 12, 2010	Los Angeles, CA	Food/Cosmetics	Voluntary Action Indicated (VAI)	2010632
Jul 9, 2010	Lancaster, PA	Drugs	Official Action Indicated (OAI)	1000150647

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1000150647	Lancaster, PA	4	Mar 24, 2021
FEI 2010632	Los Angeles, CA	4	Mar 11, 2020

Recent 510(k) clearances

2 510(k) clearances on Jun 19, 2018.

K-Number	Device	Date
K180847	Neutrogena Light Therapy Acne Mask+	Jun 19, 2018
K180856	Neutrogena Light Therapy Aging Mask+	Jun 19, 2018

Johnson & Johnson Consumer, Inc. and the FDA: common questions

Has Johnson & Johnson Consumer, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Johnson & Johnson Consumer, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Johnson & Johnson Consumer, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Johnson & Johnson Consumer, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Johnson & Johnson Consumer, Inc.?

The most recent FDA inspection on file ended Mar 24, 2021 at Lancaster, PA and was classified VAI. FDA has 8 inspections of Johnson & Johnson Consumer, Inc. on file, 1 of them classified OAI (official action indicated).

Has Johnson & Johnson Consumer, Inc. had an FDA recall?

Yes. Johnson & Johnson Consumer, Inc. has 26 FDA recalls on record, 2 of them Class I, the most serious class. The most recent started Jul 14, 2021.

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