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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| May 28, 2024 | Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Do... | Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. | Class I | Sagent Pharmaceuticals |
| Apr 25, 2024 | MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 m... | Presence of Particulate Matter: Potential for black particulates in the drug product. | Class II | Sagent Pharmaceuticals |
| Jan 23, 2024 | Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL),... | Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified ... | Class II | Baxter Healthcare Corporation |
| Jan 10, 2024 | Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Parabe... | Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while t... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 14, 2023 | Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manu... | Failed pH Specifications | Class II | Baxter Healthcare Corporation |
| Oct 20, 2023 | Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only,... | Sub-potent Drug: Lower potency than labeled. | Class III | Zyla Life Sciences US Inc. |
| Oct 17, 2023 | Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bott... | Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect bar... | Class III | AbbVie Inc. |
| Oct 4, 2023 | Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ing... | CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and release... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 24, 2023 | Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL)... | CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions dur... | Class II | Baxter Healthcare Corporation |
| Aug 17, 2023 | Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactu... | Cross contamination with other products | Class III | Lundbeck LLC |
| Aug 14, 2023 | Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial,... | Labeling: Missing Label; customer complaint received that labels were partially or completely pee... | Class III | Baxter Healthcare Corporation |
| Aug 11, 2023 | DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, p... | Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. | Class II | Baxter Healthcare Corporation |
| Aug 11, 2023 | Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FL... | Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. | Class II | Baxter Healthcare Corporation |
| Jul 11, 2023 | Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For I... | Lack of Assurance of Sterility | Class II | Sagent Pharmaceuticals |
| Jul 11, 2023 | Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, la... | Lack of Assurance of Sterility | Class II | Sagent Pharmaceuticals |
| Jul 11, 2023 | Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd... | Lack of Assurance of Sterility | Class II | Sagent Pharmaceuticals |
| May 19, 2023 | Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharm... | Lack of Assurance of Sterility | Class II | Sagent Pharmaceuticals Inc |
| May 19, 2023 | Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharm... | Lack of Assurance of Sterility | Class II | Sagent Pharmaceuticals Inc |
| May 19, 2023 | Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd... | Lack of Assurance of Sterility | Class II | Sagent Pharmaceuticals Inc |
| Apr 26, 2023 | Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, ... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx O... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intraveno... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TEC... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous U... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manuf... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured b... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Dis... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, D... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Op... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn O... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distribute... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operatin... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL amp... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distrib... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, 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.