October 1, 2025DrugsFDA
Private Label Skin Care Inc. recalls Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly
Hazard: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
October 1, 2025DrugsFDA
Private Label Skin Care Inc. recalls ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverly Hills, CA 90210
Hazard: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
October 1, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colval
Hazard: CGMP Deviations: Market complaints received for gritty texture (grainy)
October 1, 2025DrugsFDA
Consumer Product Partners, LLC recalls TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 452
Hazard: Cross Contamination with Other Products.
October 1, 2025DrugsFDA
Consumer Product Partners, LLC recalls Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC
Hazard: Cross Contamination with Other Products.
October 1, 2025DrugsFDA
YANGZHOU YULOU PAPER PRODUCTS CO., LTD recalls Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., H
Hazard: cGMP Deviations
September 24, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. B
Hazard: Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
September 24, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distribut
Hazard: Failed Impurity/Degradation Specifications
September 24, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distrib
Hazard: Failed Impurity/Degradation Specifications
September 24, 2025DrugsFDA
Unichem Pharmaceuticals USA Inc. recalls Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, L
Hazard: Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
September 24, 2025DrugsFDA
Northwind Pharmaceuticals LLC recalls Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-3
Hazard: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
September 24, 2025DrugsFDA
B BRAUN MEDICAL INC recalls 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem
Hazard: Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
September 24, 2025DrugsFDA
B BRAUN MEDICAL INC recalls STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Hazard: Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
September 24, 2025DrugsFDA
Sandoz Inc recalls Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactur
Hazard: cGMP deviations: Temperature excursion during transportation.
September 24, 2025DrugsFDA
Amerisource Health Services LLC recalls chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American
Hazard: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
September 24, 2025DrugsFDA
Amerisource Health Services LLC recalls chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American
Hazard: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
September 24, 2025DrugsFDA
Amerisource Health Services LLC recalls chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Pac
Hazard: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
September 24, 2025DrugsFDA
Amerisource Health Services LLC recalls chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual
Hazard: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
September 24, 2025DrugsFDA
Fagron Compounding Services recalls bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 871
Hazard: Lack of Assurance of Sterility
September 24, 2025DrugsFDA
Ascend Laboratories, LLC recalls Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distribute
Hazard: Superpotent drug
September 17, 2025DrugsFDA
AvKARE recalls chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKar
Hazard: Presence of a foreign substance.
September 17, 2025DrugsFDA
AvKARE recalls chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare
Hazard: Presence of a foreign substance.
September 17, 2025DrugsFDA
Lannett Company Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 10
Hazard: Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
September 17, 2025DrugsFDA
GRACE & FIRE PTY LTD recalls Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL,
Hazard: 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 64.
September 17, 2025DrugsFDA
GRACE & FIRE PTY LTD recalls Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, ND
Hazard: 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 64.
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit