Multi-event July 2021 FDA Recall Drug by Johnson & Johnson Consumer, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Johnson & Johnson Consumer, Inc. on July 14, 2021 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently ongoing.

Reported Recall Events

Recall Number: D-0833-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
a) 1,265,724 b) 1,052,544cans

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) NET WT. 6.5 OZ (184 g) (UPC 0 86800 87273 3) and b) NET WT. 8.5 oz (240 g) (UPC 0 86800 10032 4) aerosol can, Distributed by JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858

Batch or Lot Expiration Information

Lot# All lots within expiry.

Recall Number: D-0841-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
876,960 cans

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%), NET WT. 6.5 OZ (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10144 4

Batch or Lot Expiration Information

Lot# All lots within expiry.

Recall Number: D-0839-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
3,985,392 cans

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (15%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08858, UPC 0 86800 10041 6

Batch or Lot Expiration Information

Lot# All lots within expiry.

Recall Number: D-0849-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11254 9

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-0844-2021

Reason for Recall
Chemical Contamination: presence of benzene
Initiated
07-14-2021
Reported
10-06-2021
Quantity
1,437,804 cans

Recall Profile & Regulatory Data

Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11254 9

Batch or Lot Expiration Information

Lot# 16621E01, exp 5/2024

Recall Number: D-0840-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
405,264 cans

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%) aerosol can, NET WT. 5.0 OZ (141 g) Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10143 7

Batch or Lot Expiration Information

Lot# All lots within expiry.

Recall Number: D-0837-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
a) 5oz-1,282,488; b) 8oz-475,476 cans

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), a) Net Wt. 5 OZ (141 g) (UPC 0 86800 10039 3) and b) Net Wt. 8.0 oz. (226 g) (UPC 0 86800 11134 4) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ, 08858,

Batch or Lot Expiration Information

Lot# All lots within expiry.

Recall Number: D-0843-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
88,380 cans

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ. (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11154 2

Batch or Lot Expiration Information

Lot# All lots within expiry.

Recall Number: D-0832-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
a) 223,884; b) 245,880 cans

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) Net Wt 5.0 oz (141g) (UPC 0 86800 10035 5) and b) Net Wt. 8 oz. (226 g) UPC 0 86800 10031 7 aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC., Skillman, NJ 08858,

Batch or Lot Expiration Information

Lot# All lots within expiry.

Recall Number: D-0846-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
a) 3,672,204; b) 11,180 cans

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), a) NET WT. 6.5 OZ. (184 g) (UPC 0 86800 87274 0) and b) NET WT. 8.5 OZ. (240 g) (UPC 0 86800 10048 5) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-0835-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
678,384 cans

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858, UPC 0 86800 10037 9

Batch or Lot Expiration Information

Lot# All lots within expiry.

Recall Number: D-0842-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
1,448,520 cans

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50, Avobenzone 2.7%, Homosalate 5%, Octisalate 4.5%, Octocrylene 6%, Oxybenzone 4.5%. NET WT. 5.5 OZ. (155 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11033 0

Batch or Lot Expiration Information

Lot# All lots within expiry.

Recall Number: D-0850-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
N/A

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255 6

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-0831-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
134,280 cans

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 (OZ) (141 g) aerosol can, Distributed by: Johnson & Johnson Consumer Inc., Skillman, NJ 08558 UPC 3 8137-119462 9

Batch or Lot Expiration Information

Lot# All lots within expiry.

Recall Number: D-0836-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
1,611,180 cans

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 10038 6

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-0847-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
196,380 cans

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 8.0 oz. (226 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 11133 7

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-0845-2021

Reason for Recall
Chemical Contamination: presence of benzene
Initiated
07-14-2021
Reported
10-06-2021
Quantity
387,648 cans

Recall Profile & Regulatory Data

Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255 6

Batch or Lot Expiration Information

Lot# 06320E26, exp 1/2023

Recall Number: D-0838-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
2,724,480 cans

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10040 9

Batch or Lot Expiration Information

Lot# All lots within expiry.

Recall Number: D-0834-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
867,816 cans

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10036 2

Batch or Lot Expiration Information

Lot# All lots within expiry.

Recall Number: D-0848-2021

Reason for Recall
cGMP Deviations
Initiated
07-14-2021
Reported
10-06-2021
Quantity
411,180 cans

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Johnson & Johnson Consumer, Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858 UPC 0 86800 10048 5

Batch or Lot Expiration Information

Lot# All lots within expiry