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 |
|---|---|---|---|---|
| Aug 22, 2017 | Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Glucona... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 22, 2017 | Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 15, 2017 | Calcium chloride 10%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., ... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | G.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Ch... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Magnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W. Devon Av... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Sodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, B... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | MIC 25/50/50, 30mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, ... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. De... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. De... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago,... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, ... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chic... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella ... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. D... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 15, 2017 | L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chi... | Lack of Assurance of Sterility. | Class II | Bella Pharmaceuticals, Inc. |
| Aug 10, 2017 | Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg p... | Presence of Foreign Substance: customer complaint of blue foreign material identified as a portio... | Class II | Morton Grove Pharmaceuticals, Inc. |
| Aug 3, 2017 | Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g)... | Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jel... | Class II | MEDLINE INDUSTRIES INC |
| Jul 26, 2017 | Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Singl... | Presence of Particulate Matter: Silicone oil | Class II | HOSPIRA INC, LAKE FOREST |
| Jul 26, 2017 | Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Si... | Presence of Particulate Matter: Silicone oil | Class II | HOSPIRA INC, LAKE FOREST |
| Jul 26, 2017 | 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container... | Presence of Particulate Matter; stainless steel | Class II | ICU Medical Inc |
| Jul 26, 2017 | Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Si... | Presence of Particulate Matter: Silicone oil | Class II | HOSPIRA INC, LAKE FOREST |
| Jul 12, 2017 | Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlor... | Crystallization with subpotent out of specification assay results for chlorhexidine. | Class III | Akorn Inc |
| Jul 12, 2017 | Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose ... | Crystallization with subpotent out of specification assay results for chlorhexidine. | Class III | Akorn Inc |
| Jul 12, 2017 | Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlor... | Crystallization with subpotent out of specification assay results for chlorhexidine. | Class III | Akorn Inc |
| Jul 6, 2017 | 0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxt... | Lack of Assurance of Sterility: Bags have the potential to leak. | Class II | Baxter Healthcare Corporation |
| Jul 6, 2017 | 5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxte... | Lack of Assurance of Sterility: Bags have the potential to leak. | Class II | Baxter Healthcare Corporation |
| Jul 6, 2017 | Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Onl... | Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-re... | Class III | Hospira Inc., A Pfizer Company |
| Jul 6, 2017 | 0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Ba... | Lack of Assurance of Sterility: Customer complaints for leaking bags. | Class II | Baxter Healthcare Corporation |
| Jul 5, 2017 | Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only... | Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product ca... | Class II | Precision Dose Inc. |
| Jun 1, 2017 | Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Dis... | CGMP Deviations | Class II | Xttrium Laboratories Inc |
| May 22, 2017 | Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (... | Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an... | Class II | Global Marketing Enterprises, Inc. |
| May 18, 2017 | Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx o... | GMP Deviation; A foreign stopper was observed during packaging of a lot of product. | Class II | Hospira Inc., A Pfizer Company |
| May 15, 2017 | Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intrav... | Lack of assurance of sterility: customer complaints received for the presence of leaks. | Class II | Baxter Healthcare Corporation |
| May 15, 2017 | Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose ... | Lack of assurance of sterility: customer complaints received for the presence of leaks. | Class II | Baxter Healthcare Corporation |
| Apr 21, 2017 | Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Sing... | Presence of Particulate Matter: human hair found within an internal sample syringe. | Class I | Hospira Inc. |
| Apr 20, 2017 | IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit con... | Product is being recalled due to low pH value. | Class III | Akorn, Inc. |
| Mar 21, 2017 | Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) p... | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Mar 17, 2017 | LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL b... | Lack of assurance of sterility: product was found to be empty, under-filled, or leaking. | Class II | Akorn, Inc. |
| Mar 16, 2017 | Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Phar... | Subpotent Drug | Class III | Fresenius Kabi USA, LLC |
| Mar 13, 2017 | Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 m... | Failed Dissolution Specifications | Class II | Akorn Inc |
| Feb 17, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Servic... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class III | Pharmedium Services, LLC |
| Feb 17, 2017 | VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Cod... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class II | Pharmedium Services, LLC |
| Feb 17, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Servic... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class III | Pharmedium Services, LLC |
| Feb 17, 2017 | Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class II | Pharmedium Services, LLC |
| Feb 17, 2017 | Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service C... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class III | Pharmedium Services, LLC |
| Feb 17, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Servic... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class III | Pharmedium Services, LLC |
| Feb 17, 2017 | Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service C... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class III | Pharmedium Services, 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.