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Browse Drug Recalls

6,220 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,220 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 6,220 FDA drug recalls.

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DateProductReasonClassFirm
Mar 17, 2026 CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-V... Lack of Assurance of Sterility Class II Chiesi USA, Inc.
Mar 17, 2026 Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... Class II Teva Pharmaceuticals USA, Inc
Mar 17, 2026 Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... Class II Teva Pharmaceuticals USA, Inc
Mar 17, 2026 Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... Class II Teva Pharmaceuticals USA, Inc
Mar 5, 2026 Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx... Lack of Assurance of Sterility Class II Apotex Corp.
Feb 26, 2026 Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W ... Lack of Assurance of Sterility Class II New Life Pharma LLC
Feb 26, 2026 Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Vall... Lack of Assurance of Sterility Class II New Life Pharma LLC
Feb 26, 2026 Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W ... Lack of Assurance of Sterility Class II New Life Pharma LLC
Feb 26, 2026 Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W... Lack of Assurance of Sterility Class II New Life Pharma LLC
Feb 10, 2026 Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single d... Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lo... Class II LEO PHARMA INC
Feb 5, 2026 acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injecti... Lack of Assurance of Sterility Class II Fresenius Kabi Compounding, LLC
Feb 5, 2026 vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Inject... Lack of Assurance of Sterility Class II Fresenius Kabi Compounding, LLC
Feb 5, 2026 vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride In... Lack of Assurance of Sterility Class II Fresenius Kabi Compounding, LLC
Feb 5, 2026 ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride... Lack of Assurance of Sterility Class II Fresenius Kabi Compounding, LLC
Feb 5, 2026 thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection,... Lack of Assurance of Sterility Class II Fresenius Kabi Compounding, LLC
Dec 31, 2025 CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drop... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye D... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manu... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manuf... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Oct 27, 2025 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake... Lack of Assurance of Sterility: Potential for flexible container leaks. Class II Otsuka ICU Medical LLC
Oct 21, 2025 Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (1... Lack of Assurance of Sterility. Class II Bristol-Myers Squibb Company
Oct 15, 2025 Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcuta... Lack of Assurance of Sterility Class II ProRx LLC
Oct 15, 2025 Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutan... Lack of Assurance of Sterility Class II ProRx LLC
Oct 15, 2025 Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutan... Lack of Assurance of Sterility Class II ProRx LLC
Oct 15, 2025 Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcu... Lack of Assurance of Sterility Class II ProRx LLC
Oct 15, 2025 Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcuta... Lack of Assurance of Sterility Class II ProRx LLC
Oct 15, 2025 Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcu... Lack of Assurance of Sterility Class II ProRx LLC
Oct 15, 2025 Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcut... Lack of Assurance of Sterility Class II ProRx LLC
Oct 10, 2025 HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syr... Lack of Assurance of Sterility. Class II Samsung Bioepis Co., Ltd.
Oct 8, 2025 Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syring... Lack of Assurance of Sterility: Class II ASTRAZENECA PHARMACEUTICALS
Oct 3, 2025 TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only,... Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets. Class II Advanced Pharmaceutical Technology, Inc.
Sep 22, 2025 Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Vo... Lack of assurance of sterility. Class II RC Outsourcing, LLC
Sep 5, 2025 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Man... Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to po... Class II Apotex Corp.
Sep 5, 2025 Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL ... Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to po... Class II Apotex Corp.
Aug 29, 2025 bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single... Lack of Assurance of Sterility Class II Fagron Compounding Services
Aug 26, 2025 STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Beth... Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. Class II B BRAUN MEDICAL INC
Aug 26, 2025 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL... Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. Class II B BRAUN MEDICAL INC
Aug 4, 2025 Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), R... Lack of Assurance of Sterility. Class II PFIZER INC
Aug 4, 2025 Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distri... Lack of Assurance of Sterility. Class II PFIZER INC
Aug 4, 2025 Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Ste... Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. Class II B BRAUN MEDICAL INC
Aug 4, 2025 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, ... Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. Class II B BRAUN MEDICAL INC
Jul 30, 2025 Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 28... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Semaglutide with B12 for Injection, all strengths and presentations, GenoGeni... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Sterile Saline Reconstitution Solution for Injection, all strengths and prese... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGeni... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL M... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, ... Lack of Assurance of Sterility Class II GenoGenix LLC

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.