FDA Recall
Ongoing
Historical recordClass II
Elixir by Coco March Tinted 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: 35192-050-17, UPC 6 7229 99913 8
by CA BOTANA International, Inc.
- Reason
- CGMP Deviations
- Published
- December 3, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by CA BOTANA International, Inc.
- Reason
- CGMP Deviations
- Published
- December 3, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave, Santa Monica, CA 90403. NDC: 35192-055-18, UPC 8 50047 92223 6
by CA BOTANA International, Inc.
- Reason
- CGMP Deviations
- Published
- December 3, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4Pros LLC, Palm Desert, CA 92211. NDC: 35192-033-16, UPC 8 18204 02572 5
by CA BOTANA International, Inc.
- Reason
- CGMP Deviations
- Published
- December 3, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by CA BOTANA International, Inc.
- Reason
- CGMP Deviations
- Published
- December 3, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-012-02
by CA BOTANA International, Inc.
- Reason
- CGMP Deviations
- Published
- December 3, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by CA BOTANA International, Inc.
- Reason
- CGMP Deviations
- Published
- December 3, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by CA BOTANA International, Inc.
- Reason
- CGMP Deviations
- Published
- December 3, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-017-05
by CA BOTANA International, Inc.
- Reason
- CGMP Deviations
- Published
- December 3, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05
by CA BOTANA International, Inc.
- Reason
- CGMP Deviations
- Published
- December 3, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by CA BOTANA International, Inc.
- Reason
- CGMP Deviations
- Published
- December 3, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02
by CA BOTANA International, Inc.
- Reason
- CGMP Deviations
- Published
- December 3, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass I
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
by Fresenius Kabi USA, LLC
- Reason
- Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- Published
- December 3, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by Medical Products Laboratories, Inc.
- Reason
- Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
- Published
- December 3, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
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
by Otsuka ICU Medical LLC
- Reason
- 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
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14
by Otsuka ICU Medical LLC
- Reason
- 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
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
Read the full medical disclaimer.