Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
3 Class I (most serious) drug recalls reported in the last 30 days.
3,250 recalls
-
Class II Ongoing
Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent, Aluminum Chlorohydrate (19.1%), packaged in 6 oz. cans, Unilever, Dist. By Unilever, Trumbull, CT 06611 UPC 0 79400 78550 3
Reason: CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Lots, distribution and details
- Product
- Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent, Aluminum Chlorohydrate (19.1%), packaged in 6 oz. cans, Unilever, Dist. By Unilever, Trumbull, CT 06611 UPC 0 79400 78550 3
- Lots / codes
- all lots, expiry 9/30/2023
- Distribution
- Nationwide in the US
- Quantity
- unknown
- Recall started
- March 30, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0211-2024
-
Class I Ongoing
Suave 24-Hour Protection Aerosol Antiperspirant Powder scent, Aluminum Chlorohydrate (19.1%), packaged in a) 4 oz. cans (UPC 0 79400 75150 8), and b) 6 oz. cans (UPC 0 79400 78490 2), Dist. By Unilever, Trumbull, CT 0661…
Reason: Chemical contamination: presence of benzene
Lots, distribution and details
- Product
- Suave 24-Hour Protection Aerosol Antiperspirant Powder scent, Aluminum Chlorohydrate (19.1%), packaged in a) 4 oz. cans (UPC 0 79400 75150 8), and b) 6 oz. cans (UPC 0 79400 78490 2), Dist. By Unilever, Trumbull, CT 06611
- Lots / codes
- all lots, expiry 9/30/2023
- Distribution
- Nationwide in the US
- Quantity
- unknown
- Recall started
- March 30, 2022 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0210-2024
-
Class II Ongoing
All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee.
Reason: CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.
Lots, distribution and details
- Lots / codes
- All drug products sold by Family Dollar retail stores located in AL, AR, LA, MS, MO, and TN from January 1, 2021 to present.
- Distribution
- Alabama, Arkansas, Louisiana, Mississippi, Missouri, Tennessee
- Quantity
- Unknown
- Recall started
- February 18, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0641-2022
-
Class II Ongoing
Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.
Reason: Labeling – product contains undeclared ethyl alcohol
Lots, distribution and details
- Lots / codes
- Lot#:339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398 and 399
- Distribution
- USA Nationwide
- Quantity
- 135.444 bottles
- Recall started
- February 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0636-2022
-
Class II Ongoing
70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Manalapan, NJ 07726, www.tsmbrands.com, Made in Turkey, UPC 868275965765
Reason: Labeling – product contains undeclared ethyl alcohol
Lots, distribution and details
- Lots / codes
- Lot#: 39,40,41,42,43,44 and 45
- Distribution
- USA Nationwide
- Quantity
- 1.186.800 bottles
- Recall started
- February 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0635-2022
-
Class II Ongoing
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as (a) 8 OZ, UPC 8 19192 02866 8; (b) 16 OZ, UPC 8 19192 02874 3; Premium Nature, South Plainfield, NJ.
Reason: Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Lots, distribution and details
- Product
- Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as (a) 8 OZ, UPC 8 19192 02866 8; (b) 16 OZ, UPC 8 19192 02874 3; Premium Nature, South Plainfield, NJ.
- Lots / codes
- All lots within expiry and labelled as 'Made in the USA'
- Distribution
- Nationwide in the USA
- Quantity
- 487,000 bottles
- Recall started
- January 28, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0647-2022
-
Class II Ongoing
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, U…
Reason: Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Lots, distribution and details
- Product
- Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, UPC 8 19192 02830 9; Premium Nature, South Plainfield, NJ.
- Lots / codes
- All lots within expiry and labelled as 'Made in the USA'
- Distribution
- Nationwide in the USA
- Quantity
- 2,095,567 bottles
- Recall started
- January 28, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0646-2022
-
Class II Ongoing
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01
Reason: Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
Lots, distribution and details
- Lots / codes
- lot# 25910009, Exp 01/2023
- Distribution
- Nationwide in the USA
- Quantity
- 2220 100-count bottles
- Recall started
- February 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0573-2022
-
Class II Ongoing
NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream, 4 oz tubes, Manufactured for NaturesPlus 548 Broadhollow Road, Melville, NY 11747, USA
Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.
Lots, distribution and details
- Lots / codes
- Product code 4929, Lot # 23622
- Distribution
- The product went to one consignee. Natural Organics, Inc., 548 Broadhollow Rd., Melville, NY 11747.
- Quantity
- 4,214 tubes
- Recall started
- December 6, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0559-2022
-
Class II Ongoing
Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- All lots within expiry
- Distribution
- nationwide in the USA
- Quantity
- 57,994 vials
- Recall started
- December 21, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0463-2022
-
Class II Ongoing
Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50
Reason: CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Lots, distribution and details
- Product
- Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50
- Lots / codes
- Lot #: 32451 Exp. 03/2022; 32532 Exp. 04/2022; 32552 Exp. 05/2022; 32701 32733 Exp. 10/2022; 32855 Exp. 02/2023; 32872 Exp. 03/2023.
- Distribution
- Nationwide within the United States
- Quantity
- 17,113 canisters
- Recall started
- January 14, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0387-2022
-
Class II Ongoing
The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC 7 14132 00071 4
Reason: Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8
Lots, distribution and details
- Lots / codes
- Lot 2091A, exp 7/2023
- Distribution
- Nationwide
- Quantity
- 258 bottles
- Recall started
- September 28, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0364-2022
-
Class II Ongoing
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging,…
Reason: Superpotent Drug: Minimally superpotent
Lots, distribution and details
- Product
- Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64
- Lots / codes
- Lot #: 15594, Exp Date 05/2023
- Distribution
- Distributed to a wholesaler in CO who further distributed Nationwide in the USA
- Quantity
- 7,176 bottles
- Recall started
- November 30, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0296-2022
-
Class I Ongoing
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging,…
Reason: Superpotent Drug
Lots, distribution and details
- Product
- Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64
- Lots / codes
- Lot #: 16345, Exp. Date 01/2024
- Distribution
- Distributed to a wholesaler in CO who further distributed Nationwide in the USA
- Quantity
- 6,816 bottles
- Recall started
- November 30, 2021 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0295-2022
-
Class II Ongoing
Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01
Reason: Defective container: Out of specification for container integrity leading to bottles leaking.
Lots, distribution and details
- Lots / codes
- Lot #: E1220B
- Distribution
- Distributed to 5 physician consignees located in the following states: CT, FL, and KS.
- Quantity
- 72 bottles
- Recall started
- November 29, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0278-2022
-
Class III Ongoing
Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-1767-01, barcode 083921157837; c) 30-count bottles, NDC: 71335-1767-02, b…
Reason: Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Lots, distribution and details
- Product
- Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-1767-01, barcode 083921157837; c) 30-count bottles, NDC: 71335-1767-02, barcode 083922165687, d) 60-count bottles, NDC: 71335-1767-03, barcode 083923153776, e) 90-count bottles, NDC: 71335-1767-04, barcode 083924152889, f) 120-count bottles, NDC: 71335-1767-07, barcode 083927153735. Westminster Pharmaceuticals LLC, Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504 USA
- Lots / codes
- a) Lots: 164865, Exp: 2/28/2021; 162113, Exp: 8/31/2022; 160419, Exp: 2/28/2023; 160004, 155752, 154380, 153776, 152889, Exp: 8/31/2022, b) Lots: 157837, 154997, Exp: 8/31/2022, c) Lots: 165687, 160419, 160330, Exp: 2/28/2023; 159973, 159943, 159352, 159345, 158841, 155752, 152347, Exp: 8/31/2022; 152245, 152156, 152197, 151338, 151160, Exp: 7/31/2022, d) Lots: 162641, Exp: 2/28/2023; 154380, 153776, 152889, Exp: 8/31/2022, e)Lots: 158841, 152889, Exp: 8/31/2022, f) Lots: 153776, 153735, 152347, Exp: 8/31/2022
- Distribution
- Nationwide in the USA
- Quantity
- 574 Bottles
- Recall started
- September 28, 2021 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0257-2022
-
Class III Ongoing
Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, b…
Reason: Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Lots, distribution and details
- Product
- Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504.
- Lots / codes
- a) Lots: 152838, 152156, 152151, 151708, 151693, 151375, 151131, 151114, Exp: 7/31/2022, b) Lots: 152245, 151822, 151708, 151160, 151131, Exp: 7/31/2022, c) Lot #: 152614, Exp: 7/31/2022.
- Distribution
- Nationwide in the USA
- Quantity
- 119 Bottles
- Recall started
- September 28, 2021 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0256-2022
-
Class II Ongoing
Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01
Reason: Labeling: Incorrect Instructions
Lots, distribution and details
- Lots / codes
- Lot # CB21024, Exp 2/2023
- Distribution
- to be entered
- Quantity
- 1,344 bottles
- Recall started
- September 2, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0005-2022
-
Class I Ongoing
ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003…
Reason: Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Lots, distribution and details
- Product
- ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)
- Lots / codes
- All lots within expiry
- Distribution
- Nationwide in the US
- Quantity
- Unknown
- Recall started
- July 16, 2021 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0001-2022
-
Class II Ongoing
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 & J…
Reason: cGMP Deviations
Lots, distribution and details
- Product
- 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
- Lots / codes
- All lots within expiry
- Distribution
- Nationwide in US
- Quantity
- N/A
- Recall started
- July 14, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0850-2021
-
Class II Ongoing
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 & J…
Reason: cGMP Deviations
Lots, distribution and details
- Product
- 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
- Lots / codes
- All lots within expiry
- Distribution
- Nationwide in US
- Quantity
- N/A
- Recall started
- July 14, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0849-2021
-
Class II Ongoing
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 & J…
Reason: cGMP Deviations
Lots, distribution and details
- Product
- 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
- Lots / codes
- All lots within expiry
- Distribution
- Nationwide in US
- Quantity
- 411,180 cans
- Recall started
- July 14, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0848-2021
-
Class II Ongoing
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.…
Reason: cGMP Deviations
Lots, distribution and details
- Product
- 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
- Lots / codes
- All lots within expiry
- Distribution
- Nationwide in US
- Quantity
- 196,380 cans
- Recall started
- July 14, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0847-2021
-
Class II Ongoing
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.…
Reason: cGMP Deviations
Lots, distribution and details
- Product
- 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
- Lots / codes
- All lots within expiry
- Distribution
- Nationwide in US
- Quantity
- a) 3,672,204; b) 11,180 cans
- Recall started
- July 14, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0846-2021
-
Class I Ongoing
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 & J…
Reason: Chemical Contamination: presence of benzene
Lots, distribution and details
- Product
- 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
- Lots / codes
- 06320E26, exp 1/2023
- Distribution
- Nationwide in US
- Quantity
- 387,648 cans
- Recall started
- July 14, 2021 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0845-2021
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update November 5, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.