Browse Drug Recalls
6,306 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,306 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 6,306 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jul 30, 2025 | Low Solubility Peptide Reconstitution Solution for Injection, all strengths a... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC,... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and present... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC,... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations,... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, ... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 284... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix... | 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.