December 10, 2025DrugsFDA
Cipla Limited recalls Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/
Hazard: Failed Stability Specifications: Observed OOS results: eg results for colour index
December 3, 2025DrugsFDA
CA BOTANA International, Inc. recalls Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, C
Hazard: CGMP Deviations
December 3, 2025DrugsFDA
CA BOTANA International, Inc. recalls CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstems
Hazard: CGMP Deviations
December 3, 2025DrugsFDA
CA BOTANA International, Inc. recalls Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTiend
Hazard: CGMP Deviations
December 3, 2025DrugsFDA
CA BOTANA International, Inc. recalls Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.
Hazard: CGMP Deviations
December 3, 2025DrugsFDA
CA BOTANA International, Inc. recalls Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronze
Hazard: CGMP Deviations
December 3, 2025DrugsFDA
CA BOTANA International, Inc. recalls Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4P
Hazard: CGMP Deviations
December 3, 2025DrugsFDA
CA BOTANA International, Inc. recalls Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond,
Hazard: CGMP Deviations
December 3, 2025DrugsFDA
CA BOTANA International, Inc. recalls Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Do
Hazard: CGMP Deviations
December 3, 2025DrugsFDA
CA BOTANA International, Inc. recalls Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, D
Hazard: CGMP Deviations
December 3, 2025DrugsFDA
CA BOTANA International, Inc. recalls Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by
Hazard: CGMP Deviations
December 3, 2025DrugsFDA
CA BOTANA International, Inc. recalls Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA B
Hazard: CGMP Deviations
December 3, 2025DrugsFDA
CA BOTANA International, Inc. recalls Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A
Hazard: CGMP Deviations
December 3, 2025DrugsFDA
CA BOTANA International, Inc. recalls Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA
Hazard: CGMP Deviations
December 3, 2025DrugsFDA
CA BOTANA International, Inc. recalls Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Dieg
Hazard: CGMP Deviations
December 3, 2025DrugsFDA
Fresenius Kabi USA, LLC recalls 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
Hazard: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
December 3, 2025DrugsFDA
Medical Products Laboratories, Inc. recalls Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD
Hazard: Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
November 26, 2025DrugsFDA
Otsuka ICU Medical LLC recalls POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical,
Hazard: 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
November 26, 2025DrugsFDA
Otsuka ICU Medical LLC recalls POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical,
Hazard: 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
November 26, 2025DrugsFDA
Park Avenue Compounding recalls Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662
Hazard: CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Berg
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), a
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenu
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West S
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distribu
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 619
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls 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-
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
November 26, 2025DrugsFDA
DermaRite Industries, LLC recalls KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777
Hazard: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.