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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-020-02

CA BOTANA International

Class I - Dangerous

CGMP Deviations

Oct 10, 2025 Over-the-Counter View Details →

Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02

CA BOTANA International

Class I - Dangerous

CGMP Deviations

Oct 10, 2025 Other Drugs View Details →

Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0

CA BOTANA International

Class I - Dangerous

CGMP Deviations

Oct 10, 2025 Other Drugs View Details →

Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-043-17

CA BOTANA International

Class I - Dangerous

CGMP Deviations

Oct 10, 2025 Other Drugs View Details →

Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1

CA BOTANA International

Class I - Dangerous

CGMP Deviations

Oct 10, 2025 Other Drugs View Details →

Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01

Medical Products Laboratories

Class I - Dangerous

Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis

Nov 12, 2025 Other Drugs Nationwide View Details →

Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8

CA BOTANA International

Class I - Dangerous

CGMP Deviations

Oct 10, 2025 Over-the-Counter View Details →

Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

DermaRite Industries

Class I - Dangerous

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

Aug 27, 2025 Other Drugs Nationwide View Details →

KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34

DermaRite Industries

Class I - Dangerous

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

Aug 27, 2025 Other Drugs Nationwide View Details →

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 (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

DermaRite Industries

Class I - Dangerous

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

Aug 27, 2025 Other Drugs Nationwide View Details →

DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08

DermaRite Industries

Class I - Dangerous

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

Aug 27, 2025 Other Drugs Nationwide View Details →

PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08

DermaRite Industries

Class I - Dangerous

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

Aug 27, 2025 Other Drugs Nationwide View Details →

DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04

DermaRite Industries

Class I - Dangerous

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

Aug 27, 2025 Other Drugs Nationwide View Details →

PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

DermaRite Industries

Class I - Dangerous

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

Aug 27, 2025 Other Drugs Nationwide View Details →

Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04

DermaRite Industries

Class I - Dangerous

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

Aug 27, 2025 Other Drugs Nationwide View Details →

NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90

Golden State Medical Supply

Class I - Dangerous

Failed Dissolution Specifications

Oct 20, 2025 Prescription Drugs Nationwide View Details →

DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

DermaRite Industries

Class I - Dangerous

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

Aug 27, 2025 Other Drugs Nationwide View Details →

San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34

DermaRite Industries

Class I - Dangerous

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

Aug 27, 2025 Other Drugs Nationwide View Details →

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26

Otsuka ICU Medical

Class I - Dangerous

Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq

Oct 29, 2025 Prescription Drugs Nationwide View Details →

UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-266-04

DermaRite Industries

Class I - Dangerous

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

Aug 27, 2025 Other Drugs Nationwide View Details →