FDA Drug recalls

FDA drug enforcement reports cover prescription and over-the-counter drugs. openFDA publishes them roughly weekly with a Class I, II, or III classification and National Drug Codes where available.

The 50 most recent FDA Drug recalls are below. Every older recall is listed in its year archive.

Recalls by year

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)

Recent recalls

• 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, Manuf…
  FDA Drug · Class II · 2026-09-02 · Hikma Pharmaceuticals Usa
• Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2…
  FDA Drug · Class II · 2026-09-02 · Accord Healthcare
• Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Il…
  FDA Drug · Class I · 2026-09-02 · Fresenius Kabi Usa
• Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2…
  FDA Drug · Class II · 2026-09-02 · Accord Healthcare
• Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, N…
  FDA Drug · Class II · 2026-09-02 · Mallinckrodt Hospital Products
• Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9…
  FDA Drug · Class II · 2026-09-02 · Apotex
• Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 167…
  FDA Drug · Class II · 2026-09-02 · Accord Healthcare
• Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 1…
  FDA Drug · Class II · 2026-09-02 · Accord Healthcare
• Ibuprofen, 150 mg per 7.5 mL, Delivers: 7.5 mL, Conc: 20 mg/mL, Oral Suspension, 12mL Oral Syringes, Berry Flavor/Alcohol Free, Mfg By: MCN…
  FDA Drug · 2026-09-02 · Safecor Health
• Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2761…
  FDA Drug · Class II · 2026-09-02 · Accord Healthcare
• Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2…
  FDA Drug · Class II · 2026-09-02 · Accord Healthcare
• Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC…
  FDA Drug · Class II · 2026-09-02 · Accord Healthcare
• Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-77…
  FDA Drug · Class I · 2026-09-02 · B Braun Medical
• Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC…
  FDA Drug · Class II · 2026-09-02 · Accord Healthcare
• Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-…
  FDA Drug · Class II · 2026-09-02 · Accord Healthcare
• Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2…
  FDA Drug · Class II · 2026-09-02 · Accord Healthcare
• Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States,…
  FDA Drug · Class II · 2026-09-02 · Lupin Pharmaceuticals
• 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 1672…
  FDA Drug · Class II · 2026-09-02 · Accord Healthcare
• Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distri…
  FDA Drug · Class II · 2026-09-02 · Church And Dwight
• Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27…
  FDA Drug · Class II · 2026-09-02 · Accord Healthcare
• Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)1…
  FDA Drug · Class II · 2026-08-26 · American Regent
• Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x…
  FDA Drug · Class II · 2026-08-26 · American Regent
• Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0…
  FDA Drug · Class II · 2026-08-26 · American Regent
• Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Via…
  FDA Drug · Class I · 2026-08-26 · American Regent
• niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL…
  FDA Drug · Class II · 2026-08-26 · American Regent
• Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 m…
  FDA Drug · Class II · 2026-08-26 · American Regent
• 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 0517-0032-0…
  FDA Drug · Class II · 2026-08-26 · American Regent
• ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR…
  FDA Drug · Class II · 2026-08-26 · American Regent
• Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pha…
  FDA Drug · Class II · 2026-08-26 · Mylan Pharmaceuticals
• Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL M…
  FDA Drug · Class II · 2026-08-26 · American Regent
• Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 262…
  FDA Drug · Class II · 2026-08-26 · Sun Pharmaceutical Industries
• ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR…
  FDA Drug · Class II · 2026-08-26 · American Regent
• PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmeda…
  FDA Drug · Class II · 2026-08-26 · Shilpa Medicare
• Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX…
  FDA Drug · Class II · 2026-08-26 · American Regent
• Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fre…
  FDA Drug · Class I · 2026-08-26 · Fresenius Kabi Usa
• AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b…
  FDA Drug · Class II · 2026-08-26 · American Regent
• Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, M…
  FDA Drug · Class II · 2026-08-26 · Golden State Medical Supply
• PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedab…
  FDA Drug · Class II · 2026-08-26 · Shilpa Medicare
• Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactur…
  FDA Drug · Class II · 2026-08-26 · Regeneron Pharmaceuticals
• Kian Pee Wan Capsules, 30-count bottles
  FDA Drug · Class I · 2026-08-19 · Buy Herbal
• SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 380…
  FDA Drug · Class II · 2026-08-19 · Apollo Care
• Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph A…
  FDA Drug · Class I · 2026-08-19 · Victory Medical Center Pharmacy
• SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care…
  FDA Drug · Class II · 2026-08-19 · Apollo Care
• CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a…
  FDA Drug · Class II · 2026-08-19 · Prestige Brands Holdings
• Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, St…
  FDA Drug · Class I · 2026-08-19 · Baxter Healthcare
• SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste…
  FDA Drug · Class II · 2026-08-19 · Apollo Care
• TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/…
  FDA Drug · Class II · 2026-08-19 · Shoolin Pharma Chem
• SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102…
  FDA Drug · Class II · 2026-08-19 · Apollo Care
• SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801…
  FDA Drug · Class II · 2026-08-19 · Apollo Care
• TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ra…
  FDA Drug · Class II · 2026-08-19 · Shoolin Pharma Chem