FDA Drug · 2023
FDA Drug recalls in 2023
RecallRadar indexes 1,252 FDA Drug recall notices published in 2023. By classification: 67 Class I, 1,096 Class II, 89 Class III.
- SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, N…
FDA Drug · Class III · 2023-01-25 · Intersect Ent - GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations,…
FDA Drug · Class II · 2023-01-25 · Akorn - Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11
FDA Drug · Class II · 2023-01-25 · Akorn - Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn,…
FDA Drug · Class II · 2023-01-25 · Akorn - Rasagiline Mesylate Tablets 1 mg
FDA Drug · Class II · 2023-01-25 · Ascend Laboratories - Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045
FDA Drug · Class II · 2023-01-25 · Akorn - Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, G…
FDA Drug · Class II · 2023-01-25 · Akorn - Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, In…
FDA Drug · Class II · 2023-01-25 · Akorn - Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, In…
FDA Drug · Class II · 2023-01-25 · Akorn - Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10
FDA Drug · Class II · 2023-01-25 · Akorn - Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045
FDA Drug · Class II · 2023-01-25 · Akorn - Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045
FDA Drug · Class II · 2023-01-25 · Akorn - Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg pe…
FDA Drug · Class II · 2023-01-25 · Fresenius Kabi Usa - Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045
FDA Drug · Class II · 2023-01-25 · Akorn - Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per m…
FDA Drug · Class II · 2023-01-25 · Fresenius Kabi Usa - TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx On…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vial…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only,…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Hav…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way S…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - Rifampin Capsules USP, 300 mg, 30-count bottle
FDA Drug · Class II · 2023-01-18 · Lupin Pharmaceuticals - QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded b…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged b…
FDA Drug · Class II · 2023-01-18 · Remedyrepack - TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only,…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compoun…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-D…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounde…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-D…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Roc…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 3053…
FDA Drug · Class II · 2023-01-18 · Direct Rx - TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dos…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing f…
FDA Drug · Class II · 2023-01-18 · Nephron Sterile Compounding Center - TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx O…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Phar…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way S…
FDA Drug · Class II · 2023-01-18 · Northern Va Compounders Pllc - Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL)
FDA Drug · Class II · 2023-01-11 · Eugia Us - Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 597…
FDA Drug · Class III · 2023-01-11 · Jubilant Cadista Pharmaceuticals - Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59)…
FDA Drug · Class II · 2023-01-11 · Pfizer - Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded by Pine Pharmaceut…
FDA Drug · Class II · 2023-01-11 · Pine Pharmaceuticals - Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distri…
FDA Drug · Class II · 2023-01-04 · Hikma Pharmaceuticals Usa - Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc
FDA Drug · Class III · 2023-01-04 · Apotex - Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-…
FDA Drug · Class II · 2023-01-04 · Nch Life Sciences - Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
FDA Drug · Class II · 2023-01-04 · Avkare
Other years
2026 (565) · 2025 (765) · 2024 (657) · 2023 (1,252) · 2022 (1,349) · 2021 (1,016) · 2020 (1,035) · 2019 (2,152) · 2018 (1,426) · 2017 (1,073) · 2016 (1,254) · 2015 (2,020) · 2014 (1,562) · 2013 (1,377) · 2012 (434)