{"as_of":"2026-09-17T11:23:46.079Z","category":"drug","window_days":90,"matched":242,"count":25,"class_i_in_page":1,"recalls":[{"recall_number":"D-0689-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Chiesi USA, Inc.","state":"NC","country":"United States","product_type":"Drugs","reason":"Lack of Assurance of Sterility","product_description":"CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.","report_date":"2026-07-22","initiation_date":"2026-07-06","days_since_report":57,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0697-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Blaine Labs Inc","state":"CA","country":"United States","product_type":"Drugs","reason":"CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry","product_description":"TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01","report_date":"2026-07-08","initiation_date":"2026-04-08","days_since_report":71,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0643-2026","classification":"Class II","status":"Ongoing","recalling_firm":"CareFusion 213, LLC","state":"TX","country":"United States","product_type":"Drugs","reason":"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","product_description":"BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.","report_date":"2026-07-08","initiation_date":"2026-06-11","days_since_report":71,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0626-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Annora Pharma Private Limited","state":"N/A","country":"India","product_type":"Drugs","reason":"Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.","product_description":"Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60.","report_date":"2026-07-01","initiation_date":"2026-06-04","days_since_report":78,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0815-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Baxter Healthcare Corporation","state":"IL","country":"United States","product_type":"Drugs","reason":"CGMP Deviations","product_description":"Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50.","report_date":"2026-09-09","initiation_date":"2026-08-06","days_since_report":8,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0785-2026","classification":"Class II","status":"Ongoing","recalling_firm":"ACCORD HEALTHCARE, INC.","state":"NC","country":"United States","product_type":"Drugs","reason":"Subpotent Drug","product_description":"Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC  16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.","report_date":"2026-09-02","initiation_date":"2026-08-06","days_since_report":15,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0793-2026","classification":"Class II","status":"Ongoing","recalling_firm":"American Regent, Inc.","state":"NY","country":"United States","product_type":"Drugs","reason":"Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde","product_description":"Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (NDC 0517-0032-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.","report_date":"2026-08-26","initiation_date":"2026-07-24","days_since_report":22,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0698-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Blaine Labs Inc","state":"CA","country":"United States","product_type":"Drugs","reason":"CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry","product_description":"Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz  bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show Spray (isopropyl Alcohol, D-Limonene, Undecylenic Acid).  Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, San","report_date":"2026-07-08","initiation_date":"2026-04-08","days_since_report":71,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0716-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Rohto-Mentholatum (Vietnam) Co., Ltd.","state":"N/A","country":"Vietnam","product_type":"Drugs","reason":"Lack of Assurance of Sterility","product_description":"Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127,  Made in Vietnam, UPC 310742011012,  NDC 10742-8158-1","report_date":"2026-07-29","initiation_date":"2026-07-14","days_since_report":50,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0709-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Major Pharmaceuticals","state":"OH","country":"United States","product_type":"Drugs","reason":"Subpotent Drug","product_description":"Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61","report_date":"2026-07-29","initiation_date":"2026-07-13","days_since_report":50,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0662-2026","classification":"Class II","status":"Ongoing","recalling_firm":"ONESOURCE SPECIALTY PHARMA LIMITED","state":"N/A","country":"India","product_type":"Drugs","reason":"Failed Impurities/Degradation Specifications","product_description":"Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31","report_date":"2026-07-15","initiation_date":"2026-06-07","days_since_report":64,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0811-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Baxter Healthcare Corporation","state":"IL","country":"United States","product_type":"Drugs","reason":"CGMP Deviations","product_description":"Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60012 USA, NDC 0338-9640-12.","report_date":"2026-09-09","initiation_date":"2026-08-06","days_since_report":8,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0602-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Keystone Industries","state":"NJ","country":"United States","product_type":"Drugs","reason":"Defective container:may contain bottles with incomplete seals","product_description":"DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Franken, WI 54229. NDC 69634-020-30","report_date":"2026-06-24","initiation_date":"2026-05-21","days_since_report":85,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0738-2026","classification":"Class III","status":"Ongoing","recalling_firm":"Ascend Laboratories, LLC","state":"NJ","country":"United States","product_type":"Drugs","reason":"Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability","product_description":"Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.","report_date":"2026-08-05","initiation_date":"2026-07-16","days_since_report":43,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0640-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Dabur India Limited","state":"","country":"India","product_type":"Drugs","reason":"CGMP Deviations; deficiencies observed during FDA inspection","product_description":"Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.","report_date":"2026-06-24","initiation_date":"2026-06-02","days_since_report":85,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0821-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Baxter Healthcare Corporation","state":"IL","country":"United States","product_type":"Drugs","reason":"CGMP Deviations","product_description":"Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0718-12.","report_date":"2026-09-09","initiation_date":"2026-08-06","days_since_report":8,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0722-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Rohto-Mentholatum (Vietnam) Co., Ltd.","state":"N/A","country":"Vietnam","product_type":"Drugs","reason":"Lack of Assurance of Sterility","product_description":"Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1","report_date":"2026-07-29","initiation_date":"2026-07-14","days_since_report":50,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0711-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Major Pharmaceuticals","state":"OH","country":"United States","product_type":"Drugs","reason":"Subpotent Drug","product_description":"Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3563-0; NDC Blister: 0904-6956-61","report_date":"2026-07-29","initiation_date":"2026-07-13","days_since_report":50,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0813-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Baxter Healthcare Corporation","state":"IL","country":"United States","product_type":"Drugs","reason":"CGMP Deviations","product_description":"CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10.","report_date":"2026-09-09","initiation_date":"2026-08-06","days_since_report":8,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0769-2026","classification":"Class I","status":"Ongoing","recalling_firm":"Buy-Herbal","state":"NY","country":"United States","product_type":"Drugs","reason":"Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.","product_description":"Kian Pee Wan Capsules, 30-count bottles","report_date":"2026-08-19","initiation_date":"2026-03-21","days_since_report":29,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0833-2026","classification":"Class III","status":"Ongoing","recalling_firm":"Supernus Pharmaceuticals, Inc.","state":"MD","country":"United States","product_type":"Drugs","reason":"Failed dissolution specifications.","product_description":"Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.","report_date":"2026-09-09","initiation_date":"2026-08-31","days_since_report":8,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0739-2026","classification":"Class III","status":"Ongoing","recalling_firm":"Ascend Laboratories, LLC","state":"NJ","country":"United States","product_type":"Drugs","reason":"Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability","product_description":"Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.","report_date":"2026-08-05","initiation_date":"2026-07-16","days_since_report":43,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0831-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Hikma Pharmaceuticals USA INC.","state":"OH","country":"United States","product_type":"Drugs","reason":"Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).","product_description":"Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH  43228.","report_date":"2026-09-02","initiation_date":"2026-08-24","days_since_report":15,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0758-2026","classification":"Class III","status":"Ongoing","recalling_firm":"Supernus Pharmaceuticals, Inc.","state":"MD","country":"United States","product_type":"Drugs","reason":"Failed Dissolution Specifications","product_description":"Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-101-30.","report_date":"2026-07-29","initiation_date":"2026-07-06","days_since_report":50,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0703-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Major Pharmaceuticals","state":"OH","country":"United States","product_type":"Drugs","reason":"Subpotent Drug","product_description":"Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA.  NDC: 0904-6952-61","report_date":"2026-07-29","initiation_date":"2026-07-13","days_since_report":50,"voluntary_or_mandated":"Voluntary: Firm initiated"}],"note":"Class I means a reasonable probability of serious harm or death, Class II temporary or reversible harm, Class III unlikely harm. Classification is FDA's; day-counts are ours.","source":"openFDA (US Food and Drug Administration), CC0","disclaimer":"openFDA's own terms apply: do not rely on this to make decisions regarding medical care, and assume all results are unvalidated. Groupings and shares are computed by AnswerPool. Device nomenclature (GMDN) fields are excluded for licensing reasons.","refresh_after":"2026-09-18T00:00:00.000Z"}