July 8, 2026DrugsFDA
CareFusion 213, LLC recalls BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x
Hazard: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
July 8, 2026DrugsFDA
CareFusion 213, LLC recalls BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x
Hazard: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
July 8, 2026DrugsFDA
CareFusion 213, LLC recalls ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/c
Hazard: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
July 8, 2026DrugsFDA
CareFusion 213, LLC recalls BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3m
Hazard: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
July 8, 2026DrugsFDA
CareFusion 213, LLC recalls BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator
Hazard: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
July 8, 2026DrugsFDA
CareFusion 213, LLC recalls BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a)
Hazard: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
July 1, 2026DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 262476
Hazard: Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
July 1, 2026DrugsFDA
Elevate Oral Care recalls Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Bea
Hazard: sub potency
July 1, 2026DrugsFDA
Annora Pharma Private Limited recalls Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangan
Hazard: Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
July 1, 2026DrugsFDA
CareFusion 213, LLC recalls BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator,
Hazard: Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
July 1, 2026DrugsFDA
CareFusion 213, LLC recalls BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Appl
Hazard: Non-Sterility: Due to presence of Aspergillus penicillioides.
July 1, 2026DrugsFDA
CareFusion 213, LLC recalls BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator,
Hazard: Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
July 1, 2026DrugsFDA
CareFusion 213, LLC recalls BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Appli
Hazard: Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
July 1, 2026DrugsFDA
PReye LLC recalls PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO
Hazard: Lack of Assurance of Sterility
July 1, 2026DrugsFDA
ANI Pharmaceuticals, Inc. recalls hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals,
Hazard: Presence of foreign substance
July 1, 2026DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume
Hazard: Incorrect product formulation: bag did not contain copper and famotidine per label.
July 1, 2026DrugsFDA
Direct Rx recalls DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distr
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
July 1, 2026DrugsFDA
Amgen, Inc. recalls Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand O
Hazard: CGMP Deviations
July 1, 2026DrugsFDA
Amgen, Inc. recalls Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC
Hazard: Presence of Foreign Substance.
July 1, 2026DrugsFDA
Amgen, Inc. recalls Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand O
Hazard: CGMP Deviations
July 1, 2026DrugsFDA
Amgen, Inc. recalls Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand O
Hazard: CGMP Deviations
July 1, 2026DrugsFDA
Amgen, Inc. recalls Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC
Hazard: Presence of Foreign Substance.
July 1, 2026DrugsFDA
Ajanta Pharma USA Inc recalls Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Aja
Hazard: CGMP Deviations
July 1, 2026DrugsFDA
The Harvard Drug Group LLC recalls Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distribut
Hazard: Subpotent Drug
June 24, 2026DrugsFDA
Dabur India Limited recalls Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28
Hazard: CGMP Deviations; deficiencies observed during FDA inspection
June 24, 2026DrugsFDA
Dabur India Limited recalls Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 500
Hazard: CGMP Deviations; deficiencies observed during FDA inspection
June 24, 2026DrugsFDA
Dabur India Limited recalls Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne
Hazard: CGMP Deviations; deficiencies observed during FDA inspection
June 24, 2026DrugsFDA
Dabur India Limited recalls Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne,
Hazard: CGMP Deviations; deficiencies observed during FDA inspection
June 24, 2026DrugsFDA
Dabur India Limited recalls Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayon
Hazard: CGMP Deviations; deficiencies observed during FDA inspection
June 24, 2026DrugsFDA
Dabur India Limited recalls Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook
Hazard: CGMP Deviations; deficiencies observed during FDA inspection