Browse Drug Recalls
1,317 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,317 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 1,317 FDA drug recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 18, 2026 | PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Ste... | Failed Stability Specifications | Class III | AbbVie Inc. |
| 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. |
| Nov 19, 2024 | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (... | Subpotent and Superpotent Drug | Class II | Mylan Institutional, Inc. |
| Nov 19, 2024 | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton... | Subpotent and Superpotent Drug | Class II | Mylan Institutional, Inc. |
| Nov 19, 2024 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton... | Subpotent and Superpotent Drug | Class II | Mylan Institutional, Inc. |
| Oct 30, 2024 | Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled S... | Labeling: Missing Label | Class II | Baxter Healthcare Corporation |
| Sep 16, 2024 | Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye... | Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. | Class II | AbbVie Inc. |
| Sep 16, 2024 | Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointm... | Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. | Class II | AbbVie Inc. |
| Aug 1, 2024 | Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1... | Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. | Class I | Baxter Healthcare Corporation |
| Jun 21, 2024 | Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Package... | Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrec... | Class I | A-S Medication Solutions LLC |
| Jun 17, 2024 | Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextro... | Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assemb... | Class II | Baxter Healthcare Corporation |
| May 28, 2024 | Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose ... | Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. | Class I | Sagent Pharmaceuticals |
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.