Cosmetic, skin care, sunscreen, hair care and supplement recalls and enforcement reports from the U.S. Food and Drug Administration, and recalls of hair dryers, straighteners and massagers from the U.S. Consumer Product Safety Commission, newest first, from the last three years. 0 in the last 7 days.
If you have a recalled product, stop using it, keep the packaging and lot number, and follow the remedy in the notice (refund or replacement). A reaction to a cosmetic can be reported to the FDA through MedWatch; a reaction that is spreading or affecting breathing is a call to a doctor or 911, not a form.
October 8, 2026 · Generac Power Systems Inc., of Waukesha, WisconsinFace and hair · Recall 27016
Grass and debris can accumulate in the trimmer mowers and ignite, posing a risk of serious injury or death from fire and burn hazards.
DR Power Equipment Pilot and Premier Trimmer Mowers
Remedy: Consumers should stop using the recalled trimmer mowers immediately and contact DR Power Equipment for a free repair kit. If consumers have concerns about installing the repair kit, contact DR Power Equipment to schedule a free repair installation from an authorized dealer.
Source: U.S. CPSC enforcement report
September 25, 2026 · SUN PHARMACEUTICAL INDUSTRIES INCBody and bath · Class III
Failed Impurities/Degradation Specifications
Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Product of Canada, NDC 16714-249-02.
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 25, 2026 · SUN PHARMACEUTICAL INDUSTRIES INCBody and bath · Class III
Failed Impurities/Degradation Specifications
Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-0.
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 25, 2026 · SUN PHARMACEUTICAL INDUSTRIES INCBody and bath · Class III
Failed Impurities/Degradation Specifications
Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9.
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 22, 2026 · ABC Compounding Co., Inc.Body and bath · Class II
CGMP Deviations
Aerocare Sani Mango Antiseptic Hand and Body Wash, Net Contents: 1 Gallon (3.8 L), Manufactured By: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, GA 33013, UPC 711808198249
Sold: US Nationwide
Source: U.S. FDA enforcement report · Ongoing
September 22, 2026 · ABC Compounding Co., Inc.Body and bath · Class II
CGMP Deviations
People's FM-24 FOAMING High Foaming Antiseptic Hand and Body Wash, NET CONTENTS: 1000 ML 33.8 FL OZ, Distributed by: People's Janitorial Supply, 955 Main Street, Forest Park, GA 30298, 404-363-2226.
Sold: US Nationwide
Source: U.S. FDA enforcement report · Ongoing
September 22, 2026 · ABC Compounding Co., Inc.Body and bath · Class II
CGMP Deviations
Aero Foamy Mango Aloe Vera Antiseptic Hand & Body Wash, Net Contents: 1 Gallon (3.8 L), Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, 30013, UPC 711808198393
Sold: US Nationwide
Source: U.S. FDA enforcement report · Ongoing
September 22, 2026 · ABC Compounding Co., Inc.Body and bath · Class II
CGMP Deviations
Handtastic Foamy Mango Antiseptic Foam Soap Hand & Body Wash, Net Contents : 18oz (532ml), Sold by, Momar Incorporated, 1880 Ellsworth Industrial Drive, N.W., Atlanta, Georgia, 80818.
Sold: US Nationwide
Source: U.S. FDA enforcement report · Ongoing
September 17, 2026 · Jiande Pengshuai Trading Co., Ltd, of ChinaBody and bath · Recall 26778
The internal wire heating elements of the blankets and pads can overheat, posing fire and burn hazards to consumers.
JKMAX Heated Blankets and Heating Pads
Remedy: Consumers should stop using the recalled blankets and pads immediately and contact JKMax for a full refund.
Source: U.S. CPSC enforcement report
September 10, 2026 · Guang Zhou Shi Wan Te Fu Ke Ji You Xian Gong Si, dba Wantefully, of ChinaFace and hair · Recall 26754
The recalled hair dryer brushes are in violation of federal regulations for hair dryers as they lack an integrated immersion protection device, which presents a substantial product hazard to consumers and the risk of death or serious injury from electrocution or shock if the hair dryers fall into…
Wantefully Hair Dryer Brushes
Remedy: Consumers should unplug and stop using the recalled hair dryers immediately and contact Guang Zhou to receive a full refund. Consumers will be asked to cut the power cord and provide a photo of the destroyed product to [email protected].
Source: U.S. CPSC enforcement report
September 10, 2026 · Shenzhen Weihua Chenyu Technology Co., Ltd, dba Junkins, of ChinaFace and hair · Recall 26750
The recalled hair dryer brushes lack an integrated immersion protection device, which presents a substantial product hazard to consumers, posing the risk of death or serious injury from electrocution or shock if the hair dryers fall into water while plugged in to an electrical source. The recalled…
DHASUWT Hair Dryer and Blow Dryer Brushes
Remedy: Consumers should unplug and stop using the recalled hair dryers immediately and contact Junkins to receive a full refund. Consumers will be asked to cut the power cord and provide a photo of the destroyed product to [email protected].
Source: U.S. CPSC enforcement report
September 10, 2026 · PRITAM INTERNATIONAL PRIVATE LIMITEDFace and hair · Class II
CGMP Deviations.
Brush Buddies, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-520-35, Item # 88520, UPC 8 10147 88520 6
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 10, 2026 · PRITAM INTERNATIONAL PRIVATE LIMITEDFace and hair · Class II
CGMP Deviations.
evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium fluoride 0.24%) Sweet Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-620-35, Item # 88620 UPC8 10147 88620 3
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 10, 2026 · PRITAM INTERNATIONAL PRIVATE LIMITEDFace and hair · Class II
CGMP Deviations.
Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride0.243%) Watermelon Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-004-40, Item # Product code: 32730, UPC 8 50048 32730 6.
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 10, 2026 · PRITAM INTERNATIONAL PRIVATE LIMITEDFace and hair · Class II
CGMP Deviations.
BB (Brush Buddies) Advanced Whitening, Anti-Cavity Fluoride Toothpaste, (sodium fluoride 0,24%) Peppermint, Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-885-42, Item # 88542, UPC 8 10147 88542 8
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 10, 2026 · PRITAM INTERNATIONAL PRIVATE LIMITEDFace and hair · Class II
CGMP Deviations.
Brush Buddies, My Little Pony Scents Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-008-40, Item# 88270, UPC 8 10147 88270 0.
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 10, 2026 · PRITAM INTERNATIONAL PRIVATE LIMITEDFace and hair · Class II
CGMP Deviations.
BB (Brush Buddies) Cavity Protection, Anti-Cavity Fluoride Toothpaste, (sodium monofluorophosphate 0.76%) Cool Mint, 2 Value Pack, Two 3.5 oz (99g) tubes, Total Net Wt 7 oz (198g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-035-10, Item # 88543, UPC 8 10147 88543 5
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 10, 2026 · PRITAM INTERNATIONAL PRIVATE LIMITEDFace and hair · Class II
CGMP Deviations.
Brush Buddies, Hot Wheels, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-002-40, Item # 88047, UPC 8 10147 88047 8
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 10, 2026 · PRITAM INTERNATIONAL PRIVATE LIMITEDFace and hair · Class II
CGMP Deviations.
ARU, Toothpaste, Gum Health, 9 Ingredients, Soothing Mint, (stannous fluoride 0.45%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-786-35, Item # 88786 UPC 8 10147 88786 6
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 10, 2026 · PRITAM INTERNATIONAL PRIVATE LIMITEDFace and hair · Class II
CGMP Deviations.
Brush Buddies, Chocolate Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-518-35, Item # 88518, UPC 8 10147 88518 3
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 10, 2026 · PRITAM INTERNATIONAL PRIVATE LIMITEDFace and hair · Class II
CGMP Deviations.
evo, Advanced Whitening, Anticavity Fluoride Toothpaste, (sodium fluoride 0.24%) Peppermint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-886-19, Item# 88619, UPC 8 10147 88619 7
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 10, 2026 · PRITAM INTERNATIONAL PRIVATE LIMITEDFace and hair · Class II
CGMP Deviations.
ARU, Toothpaste, Cavity Protection, 9 Ingredients, Cool Mint, (sodium fluoride 0.243%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-785-35, Item # 88785, UPC 8 10147 88785
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 10, 2026 · PRITAM INTERNATIONAL PRIVATE LIMITEDFace and hair · Class II
CGMP Deviations
Brush Buddies, Vanilla Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-517-35, Item # 88517, UPC 8 10147 88517 6
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 10, 2026 · PRITAM INTERNATIONAL PRIVATE LIMITEDFace and hair · Class II
CGMP Deviations
Brush Buddies, Barbie, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-001-40, Item# 88022, UPC 8 10147 88022 5
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 10, 2026 · PRITAM INTERNATIONAL PRIVATE LIMITEDFace and hair · Class II
CGMP Deviations.
Brush Buddies, Whitening Anti-cavity Fluoride Toothpaste, with Baking Soda, (sodium monofluorophosphate 0.76%) Cool Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-007-07, ITEM # 999131, 8 50010 84249 3
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 10, 2026 · PRITAM INTERNATIONAL PRIVATE LIMITEDFace and hair · Class II
CGMP Deviations.
Brush Buddies, Cookies 'n Cream Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-519-35, Item # 88519, UPC 8 10147 88519 0
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
September 1, 2026 · SV Labs Toronto CorporationBody and bath · Class II
Microbial contamination of topical product.
Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0536-1261-63), and b) 8.5 FL OZ (237 mL) bottles (NDC 0536-1351-42), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152.
Sold: IL only
Source: U.S. FDA enforcement report · Ongoing
September 1, 2026 · SV Labs Toronto CorporationBody and bath · Class II
Microbial contamination of topical product.
Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1259-63
Sold: IL only
Source: U.S. FDA enforcement report · Ongoing
August 21, 2026 · Lexia LLCBody and bath · Class II
CGMP Deviations: Potential contamination of raw material
Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-5, UPC 8 50041 64003 7
Sold: Distributed in the state of Colorado (US).
Source: U.S. FDA enforcement report · Ongoing
August 21, 2026 · Lexia LLCBody and bath · Class II
CGMP Deviations: Potential contamination of raw material
Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil 2000mg),4 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-6; UPC 8 50041 64004 4
Sold: Distributed in the state of Colorado (US).
Source: U.S. FDA enforcement report · Ongoing
August 14, 2026 · Allies Group Inc.Face and hair · Class II
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293
Sold: Nationwide within the U.S.A
Source: U.S. FDA enforcement report · Ongoing
August 8, 2026 · SHANTOU Qiwei industrial Co., LtdFace and hair · Class II
cGMP Deviations
MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building, Yingloinguan, Xiashan, Chaonan district, Shantou City, Guangdong Province, China
Sold: CA only
Source: U.S. FDA enforcement report · Ongoing
August 3, 2026 · Lupin Pharmaceuticals Inc.Body and bath · Class II
Failed content uniformity specifications.
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.
Sold: USA Nationwide
Source: U.S. FDA enforcement report · Ongoing
July 9, 2026 · Greenworks North America, LLC, dba Greenworks Tools, of Mooresville, North CarolinaFace and hair · Recall 26611
Charging the lithium-ion batteries through the USB-C port, while the batteries are inserted in the yard power tools can cause the batteries to short-circuit, posing a risk of serious injury from fire hazard.
Kobalt 24V and 48V Trimmers, Blowers, Mowers, Chainsaws and Pruning Saws with USB-C Batteries
Remedy: Consumers should stop charging the batteries with the USB-C port while the batteries are inserted in the yard power tools immediately and contact Greenworks Tools to receive a free replacement battery. Consumers will be asked to complete the registration form at https://www.greenworkstools.com/pages/kobalt-product-recall to receive replacement batteries without the USB-C port, a charger adapter, a warning label to affix on the yard power tool, an updated product manual and a pre-paid shipping label along with instructions for returning the recalled batteries.
Source: U.S. CPSC enforcement report
June 23, 2026 · Padagis US LLCBody and bath · Class II
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35
Sold: USA Nationwide
Source: U.S. FDA enforcement report · Ongoing
June 11, 2026 · BioMed Laboratories, LLC.Body and bath · Class II
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13 4 FL OZ (118 mL) NDC 53329-159-04
Sold: Nationwide in the US
Source: U.S. FDA enforcement report · Ongoing
June 2, 2026 · Dabur India LimitedBody and bath · Class II
CGMP Deviations; deficiencies observed during FDA inspection
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
June 2, 2026 · Dabur India LimitedBody and bath · Class II
CGMP Deviations; deficiencies observed during FDA inspection
Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10461 5.
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
June 2, 2026 · Dabur India LimitedBody and bath · Class II
CGMP Deviations; deficiencies observed during FDA inspection
Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2.
Sold: US Nationwide.
Source: U.S. FDA enforcement report · Ongoing
April 24, 2026 · Wisconsin Pharmacal CompanyBody and bath · Class I
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037.
Sold: USA Nationwide and Bahamas
Source: U.S. FDA enforcement report · Ongoing
April 8, 2026 · Blaine Labs IncBody and bath · Class II
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show Spray (isopropyl…
Sold: Nationwide in the USA
Source: U.S. FDA enforcement report · Ongoing
April 8, 2026 · Blaine Labs IncBody and bath · Class II
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2.
Sold: Nationwide in the USA
Source: U.S. FDA enforcement report · Ongoing
April 8, 2026 · Blaine Labs IncBody and bath · Class II
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01.
Sold: Nationwide in the USA
Source: U.S. FDA enforcement report · Ongoing
April 1, 2026 · Island Kinetics, Inc. d.b.a. CoValence LaboratoriesBody and bath · Class II
Failed Stability Specifications
Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
Sold: U.S. Nationwide
Source: U.S. FDA enforcement report · Ongoing
March 25, 2026 · SUN PHARMACEUTICAL INDUSTRIES INCBody and bath · Class II
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.
Sold: Nationwide in the USA.
Source: U.S. FDA enforcement report · Ongoing
March 25, 2026 · SUN PHARMACEUTICAL INDUSTRIES INCBody and bath · Class II
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.
Sold: Nationwide in the USA.
Source: U.S. FDA enforcement report · Ongoing
March 25, 2026 · SUN PHARMACEUTICAL INDUSTRIES INCBody and bath · Class II
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1
Sold: Nationwide in the USA.
Source: U.S. FDA enforcement report · Ongoing
March 18, 2026 · Island Kinetics, Inc. d.b.a. CoValence LaboratoriesBody and bath · Class III
Subpotent Drug
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
Sold: U.S. Nationwide
Source: U.S. FDA enforcement report · Terminated
March 18, 2026 · Island Kinetics, Inc. d.b.a. CoValence LaboratoriesBody and bath · Class III
Subpotent Drug
Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05
Sold: U.S. Nationwide
Source: U.S. FDA enforcement report · Terminated
March 18, 2026 · Island Kinetics, Inc. d.b.a. CoValence LaboratoriesBody and bath · Class III
Subpotent Drug
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04
Sold: U.S. Nationwide
Source: U.S. FDA enforcement report · Terminated
