{"as_of":"2026-09-15T12:43:42.068Z","category":"drug","window_days":365,"matched":891,"count":25,"class_i_in_page":1,"recalls":[{"recall_number":"D-0115-2026","classification":"Class II","status":"Ongoing","recalling_firm":"ProRx LLC","state":"PA","country":"United States","product_type":"Drugs","reason":"Lack of Assurance of Sterility","product_description":"Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341.  NDC:  84139-225-04","report_date":"2025-11-05","initiation_date":"2025-10-15","days_since_report":314,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0081-2026","classification":"Class II","status":"Ongoing","recalling_firm":"GenoGenix  LLC","state":"FL","country":"United States","product_type":"Drugs","reason":"Lack of Assurance of Sterility","product_description":"Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial and Medical Health Institute (MHI), a) 10 % Exosomes, 2mL vial, 5mL vial, 10mL ","report_date":"2025-10-15","initiation_date":"2025-07-30","days_since_report":335,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0301-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Unichem Pharmaceuticals USA Inc.","state":"NJ","country":"United States","product_type":"Drugs","reason":"cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.","product_description":"Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01","report_date":"2026-02-11","initiation_date":"2026-01-21","days_since_report":216,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"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":55,"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":69,"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":69,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0353-2026","classification":"Class I","status":"Ongoing","recalling_firm":"McKesson","state":"TX","country":"United States","product_type":"Drugs","reason":"Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.","product_description":"UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only,  Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63","report_date":"2026-02-18","initiation_date":"2026-01-16","days_since_report":209,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0558-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Guardian Drug Co. Inc.","state":"NJ","country":"United States","product_type":"Drugs","reason":"Presence of foreign substance: small metallic particles in chewable tablets.","product_description":"HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2.","report_date":"2026-06-10","initiation_date":"2026-05-28","days_since_report":97,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0646-2025","classification":"Class II","status":"Ongoing","recalling_firm":"Fagron Compounding Services","state":"KS","country":"United States","product_type":"Drugs","reason":"Lack of Assurance of Sterility","product_description":"bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226","report_date":"2025-09-24","initiation_date":"2025-08-29","days_since_report":356,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0054-2026","classification":"Class II","status":"Ongoing","recalling_firm":"GenoGenix  LLC","state":"FL","country":"United States","product_type":"Drugs","reason":"Lack of Assurance of Sterility","product_description":"Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692","report_date":"2025-10-15","initiation_date":"2025-07-30","days_since_report":335,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0051-2026","classification":"Class II","status":"Ongoing","recalling_firm":"GenoGenix  LLC","state":"FL","country":"United States","product_type":"Drugs","reason":"Lack of Assurance of Sterility","product_description":"GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.","report_date":"2025-10-15","initiation_date":"2025-07-30","days_since_report":335,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0323-2026","classification":"Class II","status":"Ongoing","recalling_firm":"F.H. INVESTMENTS, Inc. (dba Asteria Health)","state":"AL","country":"United States","product_type":"Drugs","reason":"Presence of Foreign substance - potential presence of metal particulate matter","product_description":"Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.","report_date":"2026-02-18","initiation_date":"2026-01-26","days_since_report":209,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0493-2026","classification":"Class II","status":"Ongoing","recalling_firm":"The Harvard Drug Group LLC","state":"OH","country":"United States","product_type":"Drugs","reason":"Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.","product_description":"Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288.  NDC: 0904-7495-06","report_date":"2026-04-29","initiation_date":"2026-04-09","days_since_report":139,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0662-2025","classification":"Class II","status":"Ongoing","recalling_firm":"Glenmark Pharmaceuticals Inc., USA","state":"NJ","country":"United States","product_type":"Drugs","reason":"CGMP Deviations: Market complaints received for gritty texture (grainy)","product_description":"Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52","report_date":"2025-10-01","initiation_date":"2025-09-17","days_since_report":349,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0668-2025","classification":"Class II","status":"Ongoing","recalling_firm":"Private Label Skin Care Inc.","state":"CA","country":"United States","product_type":"Drugs","reason":"Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.","product_description":"edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ.","report_date":"2025-10-01","initiation_date":"2025-09-12","days_since_report":349,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0062-2026","classification":"Class II","status":"Ongoing","recalling_firm":"GenoGenix  LLC","state":"FL","country":"United States","product_type":"Drugs","reason":"Lack of Assurance of Sterility","product_description":"Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.","report_date":"2025-10-15","initiation_date":"2025-07-30","days_since_report":335,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0554-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Spectra Medical Devices, Llc","state":"MA","country":"United States","product_type":"Drugs","reason":"Lack of Assurance of Sterility","product_description":"Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.","report_date":"2026-06-10","initiation_date":"2026-05-12","days_since_report":97,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0191-2026","classification":"Class II","status":"Ongoing","recalling_firm":"CA BOTANA International, Inc.","state":"CA","country":"United States","product_type":"Drugs","reason":"CGMP Deviations","product_description":"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","report_date":"2025-12-03","initiation_date":"2025-10-10","days_since_report":286,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0407-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Apotex Corp.","state":"FL","country":"United States","product_type":"Drugs","reason":"Lack of Assurance of Sterility","product_description":"Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.","report_date":"2026-03-25","initiation_date":"2026-03-05","days_since_report":174,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0116-2026","classification":"Class II","status":"Ongoing","recalling_firm":"ProRx LLC","state":"PA","country":"United States","product_type":"Drugs","reason":"Lack of Assurance of Sterility","product_description":"Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341.  NDC:  84139-225-08","report_date":"2025-11-05","initiation_date":"2025-10-15","days_since_report":314,"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":76,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0476-2026","classification":"Class II","status":"Ongoing","recalling_firm":"SUN PHARMACEUTICAL INDUSTRIES INC","state":"NJ","country":"United States","product_type":"Drugs","reason":"Failed Viscosity Specifications:  Out of Specification results, above the specification limit, in viscosity, noted during stability testing.","product_description":"Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.","report_date":"2026-04-22","initiation_date":"2026-03-25","days_since_report":146,"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":6,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0501-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Thea Pharma, Inc.","state":"MA","country":"United States","product_type":"Drugs","reason":"Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.","product_description":"Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11","report_date":"2026-05-06","initiation_date":"2026-04-23","days_since_report":132,"voluntary_or_mandated":"Voluntary: Firm initiated"},{"recall_number":"D-0597-2026","classification":"Class II","status":"Ongoing","recalling_firm":"Ascend Laboratories, LLC","state":"NJ","country":"United States","product_type":"Drugs","reason":"Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis","product_description":"Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.  NDC: 67877-644-30","report_date":"2026-06-17","initiation_date":"2026-06-01","days_since_report":90,"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."}