Browse Drug Recalls

1,327 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,327 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 1,327 FDA drug recalls in IL.

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DateProductReasonClassFirm
Aug 10, 2026 Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx ... Presence of particulate matter:An internal investigation at the firm found the product to contain... Class I Fresenius Kabi USA, LLC
Aug 4, 2026 Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefille... Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of ... Class I Fresenius Kabi USA, LLC
Jul 24, 2026 Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Inf... Presence of Particulate Matter Class I Baxter Healthcare Corporation
Jul 16, 2026 Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill... Presence of Particulate Matter: Hair was found in product Class II Fresenius Kabi USA, LLC
Jul 16, 2026 Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL)... Presence of Particulate Matter: Hair was found in products Class II Fresenius Kabi USA, LLC
Jul 16, 2026 Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single D... Presence of Particulate Matter: Hair was found in products Class II Fresenius Kabi USA, LLC
Jul 16, 2026 Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL)... Presence of Particulate Matter: Hair was found in products Class II Fresenius Kabi USA, LLC
Jul 16, 2026 Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5... Presence of Particulate Matter: Hair was found in products Class II Fresenius Kabi USA, LLC
Jul 14, 2026 Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precisi... Failed Impurities/Degradation Specifications Class II Precision Dose Inc.
May 18, 2026 PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Ste... Failed Stability Specifications Class III AbbVie Inc.
May 14, 2026 Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius... Failed Impurities/Degradations Specifications Class III Fresenius Kabi USA, LLC
May 4, 2026 Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials,... Failed Impurities/Degradation Specifications Class III Sagent Pharmaceuticals
Mar 11, 2026 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL i... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, ... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 ... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL f... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 m... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL f... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL i... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 ... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 1... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL),... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 ... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Feb 9, 2026 Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx... Defective Delivery System: Missing or duplicated needles within the injection kit Class II Meitheal Pharmaceuticals, Inc
Dec 22, 2025 Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Ba... Presence of particulate matter: plastic particles from the bottle rim were observed floating into... Class II Baxter Healthcare Corporation
Nov 6, 2025 Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only... Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. Class I Fresenius Kabi USA, LLC
Sep 29, 2025 Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per... Subpotent Drug Class II Medline Industries, LP
Aug 20, 2025 Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo ... Discoloration Class II Baxter Healthcare Corporation
Aug 19, 2025 READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile,... Subpotent drug Class III Medline Industries, LP
Jul 7, 2025 H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China wi... Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 7, 2025 RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200... Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 7, 2025 Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Sin... Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 7, 2025 ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walm... Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 7, 2025 CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton... Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 7, 2025 Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen,... Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 7, 2025 Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose ... Super-Potent Drug: Out of specification potency results were obtained. Class II Mylan Institutional, Inc.
Mar 7, 2025 Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose... Super-Potent Drug: Out of specification potency results were obtained. Class II Mylan Institutional, Inc.
Feb 25, 2025 METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-... Presence of Foreign Tablets/Capsules. Class II A-S Medication Solutions LLC
Feb 17, 2025 Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Sin... Subpotent Drug Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 17, 2025 CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton... Subpotent Drug Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case,... Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain ... Class I ICU Medical, Inc.
Feb 13, 2025 POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container... Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may... Class I ICU Medical, Inc.
Dec 23, 2024 Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, ... Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules Class I Astellas Pharma US Inc.
Dec 23, 2024 Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Produc... Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules Class I Astellas Pharma US Inc.
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton... Subpotent and Superpotent Drug Class II Mylan Institutional, Inc.
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton... Subpotent and Superpotent Drug Class II Mylan Institutional, Inc.
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton... Subpotent and Superpotent Drug Class II Mylan Institutional, Inc.

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.