FDA Drug Recalls

723 recalls, newest first

Class II · Moderate risk Ongoing Aug 27, 2025

San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ…

Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaRite Industries, LLC NDC 61924-107-34 D-0176-2026

Class II · Moderate risk Ongoing Aug 27, 2025

Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800…

Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaRite Industries, LLC NDC 61924-405-05 D-0175-2026

Class II · Moderate risk Ongoing Aug 27, 2025

Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North…

Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaRite Industries, LLC NDC 61924-435-04 D-0174-2026

Class II · Moderate risk Ongoing Aug 27, 2025

PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC…

Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaRite Industries, LLC NDC 61924-205-05 D-0173-2026

Class II · Moderate risk Ongoing Aug 27, 2025

PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side…

Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaRite Industries, LLC NDC 61924-198-08 D-0172-2026

Class II · Moderate risk Ongoing Aug 27, 2025

McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distributed by…

Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaRite Industries, LLC NDC 68599-6202-1 D-0171-2026

Class II · Moderate risk Ongoing Aug 27, 2025

Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC…

Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaRite Industries, LLC NDC 61924-304-05 D-0170-2026

Class II · Moderate risk Ongoing Aug 27, 2025

Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-04), and…

Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaRite Industries, LLC NDC 61924-504-05 D-0169-2026

Class II · Moderate risk Ongoing Aug 27, 2025

KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side…

Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaRite Industries, LLC NDC 61924-093-34 D-0168-2026

Class II · Moderate risk Ongoing Aug 27, 2025

Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per…

Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaRite Industries, LLC NDC 61924-102-08 D-0167-2026

Class II · Moderate risk Ongoing Aug 27, 2025

GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL…

Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaRite Industries, LLC NDC 61924-106-04 D-0166-2026

Class II · Moderate risk Ongoing Aug 27, 2025

DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue…

Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaRite Industries, LLC NDC 61924-189-08 D-0165-2026

Class II · Moderate risk Ongoing Aug 27, 2025

DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777…

Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaRite Industries, LLC NDC 61924-214-04 D-0164-2026

Class II · Moderate risk Ongoing Aug 27, 2025

DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube…

Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaRite Industries, LLC NDC 61924-092-08 D-0163-2026

Class II · Moderate risk Ongoing Aug 27, 2025

DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g…

Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaRite Industries, LLC NDC 61924-234-05 D-0162-2026

Class II · Moderate risk Ongoing Aug 27, 2025

DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and…

Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaRite Industries, LLC NDC 61924-174-04 D-0161-2026

Class II · Moderate risk Ongoing Aug 27, 2025

4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side…

Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaRite Industries, LLC NDC 61924-208-04 D-0160-2026

Class II · Moderate risk Ongoing Aug 26, 2025

0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA…

Reason Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

B Braun Medical INC NDC 0264-7388-60 D-0653-2025

Class II · Moderate risk Ongoing Aug 26, 2025

STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.

Reason Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

B Braun Medical INC NDC 0264-7385-60 D-0652-2025

Class III · Low risk Ongoing Aug 25, 2025

TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC…

Reason Cross Contamination with Other Products.

Consumer Product Partners, LLC D-0661-2025

Class III · Low risk Ongoing Aug 25, 2025

Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC…

Reason Cross Contamination with Other Products.

Consumer Product Partners, LLC D-0660-2025

Class II · Moderate risk Ongoing Aug 25, 2025

chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare…

Reason Presence of a foreign substance.

AvKARE NDC 50268-165-15 D-0644-2025

Class II · Moderate risk Ongoing Aug 25, 2025

chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare…

Reason Presence of a foreign substance.

AvKARE NDC 50268-164-15 D-0643-2025

Class II · Moderate risk Ongoing Aug 22, 2025

Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl…

Reason Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and…

Grace & Fire Pty LTD NDC 84803-110-01 D-0641-2025

Class II · Moderate risk Ongoing Aug 22, 2025

Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC…

Reason Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and…

Grace & Fire Pty LTD NDC 84803-106-01 D-0640-2025